Job description: Location :

Open University Supervisory team: Claire Batty; Geraint Morgan; Vic Pearson.

Project Highlights:

• Opportunity to develop expertise in cutting edge volatile organic compound detection and analysis for contamination detection.
• Opportunity to develop skills in analytical techniques, contamination control, and materials and process (M&P) protocols within the space sector.
• This industrial CASE studentship is a collaboration between The Open University (OU) and Airbus Defence and Space Ltd (Airbus DS) providing both academic and industrial research experience.

Overview:

The STFC Industrial CASE (Cooperative Awards in Science and Technology) studentship provides a 3.5-year stipend that allows the student to spend periods of time on placement at Airbus DS in Stevenage, UK. The cumulative placement period will be no less than 9 months but this will be spread over the period of the studentship and will not normally exceed 18 months.

Protecting the space environment is a critical 21st century challenge to ensure the space sector remains environmentally sustainable and socially responsible. For those that manufacture space and satellite equipment, contamination resulting from surfaces, people and materials is a particular problem that is poorly understood but could have serious adverse impacts on extra-terrestrial environments.

Many materials used in the manufacture of spacecraft, particularly those used for bonding, are silicone-based. This is because they are easy to use, work well in a large range of temperatures, have good adhesion and are UV and ozone resistant. Certain silicones emit low levels of volatile gases. However, in the space environment, there are both thermal and vacuum effects that increase outgassing of certain compounds that can settle on sensitive equipment causing parts, such as lenses, to become contaminated and image quality to be reduced. If they are deposited on equipment that lands on a celestial body, this could contaminate other natural environments, including those that might be habitable.

This studentship builds on a successful Open University/Airbus DS STFC Impact Accelerator Account project (scheme can be found online) and will apply a novel approach to volatile analysis within space sector cleanrooms.

The aims of this studentship are: * To identify, profile and catalogue volatile, semi-volatile and surface organic compounds in cleanrooms and understand the influence of VOCs on bonding, and cleaning methodologies.

• To develop techniques, in partnership with the Airbus technical team, to help identify individual contamination compounds, and assess risk of silicone contamination vs cure.
• To develop analytical strategies to then deal with real time contamination events.
• To develop and optimise analytical methods for flight hardware, cleanroom surfaces and air.

Training and skills:

The Open University (OU) is based in Milton Keynes where the student will receive training in chromatography and mass spectrometry techniques to facilitate the identification of organic compounds. These techniques will include Thermal Desorption Gas Chromatography Mass Spectrometry (TD-GC-MS), additional headspace analysis techniques, and Selective Ion Flow Tube Mass Spectrometry (SIFT-MS).

The student will receive training in M&P protocols in line with contamination control at Airbus’ Stevenage site, which focuses on spacecraft manufacturing and played a key role in the assembly of the ExoMars rover. They will have the opportunity to shadow the M&P staff and cleanliness control engineers when on site. They will learn how cleanrooms function, ISO standards and why specialist clothing is required for the different ISO standards. They will be able to observe the current laboratory techniques in use (FTIR) and be able to compare these to their own methods/results.

The student will benefit from bespoke training organised by the School of Earth, Environment and Ecosystem Sciences (EEES) and by AstrobiologyOU, including mandated training, such as health and safety and laboratory skills. They will benefit from being a member of a cross-school research group, with relevant in-house training. AstrobiologyOU offers dedicated training events and seminars, including CV-writing support, managing budgets and fellowship writing training. AstrobiologyOU is committed to identifying teaching opportunities for any student that desires them and offering public engagement opportunities to support communication skills development.

Possible timeline:

Year 1: Perform a literature review and create initial databases of cleanroom compounds. Initial placements (likely 2 weeks in duration) at Airbus for materials and processes training, and sample collection. Training on analytical equipment.

Year 2: Optimise techniques and react to real time events that occur. Further placements (between 2-4 weeks each) to continue sample collection and react to contamination events. Presentation at national/international conference.

Year 3-3.5: Consolidation of all techniques and develop final protocols. Further placement, conference presentations. Thesis writing and submission.

Further reading:

Further details:

Students should have a strong background in analytical chemistry and/or materials chemistry, and an interest in planetary or space science. The PhD student will be a member of the School of Earth, Environment and Ecosystems Sciences and the cross-faculty , and will join a vibrant postgraduate community at the Open University.

Please contact Dr Claire Batty ( ) for further information.

Applications should include:

• a cover letter outlining why the project is of interest to you and how your skills match those required.
• an academic CV containing contact details of two academic references.
• an OU application form, downloadable from: –

• UK applicants:

• International Applicants:

Applications should be sent to by 12pm (noon) on 29th January 2024

£22,997 stipend

Expected salary: £22997 per year

Location: Milton Keynes

Job date: Wed, 13 Dec 2023 04:07:13 GMT

Apply for the job now!

The post PhD Studentship: Development and Validation of Innovative, Near Real-time Analytical Tools to Enable Mitigation of Contamination within Cleanrooms of the UK Spacecraft & Satellite Industry appeared first on World News: Entertainment, lifestyle, Health, Technology.

Job description: Lead Process Engineer, Validation & Quality

Job Description

As a person, you’re a learner – a natural leader – someone who is always taking initiative to make things better and bring others along with you. You live your life in alignment with the highest values of integrity and quality, always ensuring your responsibilities become a long-term success story. In this role, you’ll help us deliver better care for billions of people around the world. It starts with YOU.

The Process Engineer – Validation & Quality, will provide Validation leadership for Baby Wipes. The position will work close with K-C’s process validation experts applying advanced knowledge and principles to R&E and manufacturing processes that directly impact business operations. It will lead the necessary activities required to support existing products/processes and changes associated with new products and processes. This includes Validation activities associated with product and process changes, enhancements, and material related process changes. The incumbent reports to the Site Quality Manager.

In this role, you will:

• Carry out all job responsibilities in a safe manner. Develop and deliver equipment and processes that meet safety requirements, policies, and guidelines. Provide for the safety and well-being of operators, maintenance, and other personnel.
• Observe all applicable quality procedures and regulations. Perform tasks utilizing Good Manufacturing Practices. Improve process capability to deliver a reduction in defects and variability. Identify, develop, and implement products, processes, materials, systems, and procedures to achieve business objectives in an FDA-regulated facility.
• Develop, execute, and review validation protocols (IQ, OQ, PQ and CSV), specification requirement documents (URS, FRS), test plans, project plans and procedures. Responsibilities include computer validation for manufacturing and related automation systems, formulation and solution validations, and validation of packaging and manufacturing processes and equipment.
• Lead validation activities to support projects and ongoing mill operation, including maintaining the Site Master Validation Plan.
• Establish the overall qualification/ validation requirements and strategies for new and modified processes related to material changes, process / product changes, and equipment changes or upgrades using risk-based methods.
• Partner with cross functional teams using LEAN problem-solving techniques to identify root cause and mitigations of process issues as they arise during operation. Where appropriate, incorporate tools such as Design of Experiments and Lean Six Sigma concepts to solve product /process nonconformance issues.
• Train and develop other site Validation Engineers as needed.

About Us

Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn’t exist without talented professionals, like you.

At Kimberly-Clark, you’ll be part of the best team committed to driving innovation, growth and impact. We’re founded on more than 150 years of market leadership, and we’re always looking for new and better ways to perform – so there’s your open door of opportunity. It’s all here for you at Kimberly-Clark.

Led by Purpose. Driven by You.

About You

You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.

You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we’re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you’ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.

In one of our professional roles, you’ll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center.

Job Requirements:

• Bachelor’s degree in Engineering, Life science, or related discipline with 3+ years of process validation experience in an FDA (cosmetic or medical device) regulated manufacturing site.
• Experience developing, leading, and executing various validations in a regulated environment.
• Experience and familiarity with Quality Management System requirements for consumer products and applicable regulatory requirements for cosmetics, including knowledge of ISO 22716 preferred.
• Demonstrated knowledge of GMP regulations and good documentation practices is required.
• Practical knowledge on risk management processes (e.g. FMEA, etc.), statistical data analysis, and change control.
• Strong verbal and written communication skills.
• A demonstrated ability working as part of a cross-functional team to achieve objectives within required time frames.
• Experience with Lean Manufacturing principles, structured problem-solving methodologies (Lean, Six Sigma, etc.), and process control.

Total Benefits

Here are a few of the benefits you’d enjoy. For a complete overview, see .

• Great support for good health with medical, dental, and vision coverage options. No waiting periods or pre-existing condition restrictions. Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.
• Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.
• Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.
• Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.

To Be Considered

Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.

In the meantime, please check out the .

And finally, the fine print….

For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check.

Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 – when prompted for employee ID, say “OTHER CALLER” – or for assistance. You must include the six digit Job # with your request.

Veterans and members of the Reserve and Guard are highly encouraged to apply.

This role is available for local candidates already authorized to work in the role’s country only.

Kimberly-Clark will support in-country relocation for the chosen candidate for the role. The benefits provided will be per the terms of Kimberly-Clark’s applicable mobility policies. The benefits/policy provided will decided in Kimberly-Clark’s sole discretion.

#LI-Onsite

Primary Location USA-AR-Maumelle

Additional Locations

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time

Expected salary:

Location: Maumelle, AR

Job date: Fri, 17 Nov 2023 07:18:52 GMT

Apply for the job now!

The post Lead Process Engineer, Validation & Quality appeared first on World News: Entertainment, lifestyle, Health, Technology.

Job description: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Senior Validation Quality Engineer

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1

Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays

Company Paid Pension Plan

401(k) retirement savings with a generous company match of 5%

Tuition reimbursement, the student debt program and education benefit – an affordable and convenient path to getting a bachelor’s degree.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Our location in Abbott Park, IL currently has an opportunity for a Senior Validation Quality Engineer

The Opportunity

The Senior Quality Engineer will function as the regional SME providing Validation support, consultation, and training to Abbott Nutrition (AN) manufacturing sites. This position will also interface with other regional SMEs to capture and share best practices globally.

WHAT YOU’LL DO

Primary Job Functions:

Lead global community of practice meetings to exchange best practices.

Develop and track validation related metrics.

Provide validation training and consultation services on validation policies and practices.

Work closely with regional engineering and site quality personnel providing expertise and guidance for verifying and validating new products and processes.

Collaborate on the definition of the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.

Assess validation documentation from DQ through protocol execution from a technical and quality perspective, provide feedback and coaching to improve division-wide validation execution, and escalate potential gaps to leadership

Provide risk management training and facilitation for FMEA development sessions.

Review, analyze and provide recommendations for verification and validation test data, including sampling strategy and statistical analysis

Provide guidance on resolving deviations associated with verification and validation activities.

Collaborate on quality system owner functions such as procedure and template writing and continuous improvement updates and global CAPA impact assessment at the division and site level

Attend site and project VRBs to support validation strategy development, protocol review, and provide coaching and feedback to VRB members.

What You’ll Work On

Lead regional community of practice meetings to exchange best practices.

Develop and track validation related metrics.

Provide validation training and consultation services on validation policies and practices.

Work closely with regional engineering and quality personnel providing expertise and guidance for verifying and validating new products and processes.

Provide guidance on change impact assessment and associated deliverable requirements for changes to systems under change control.

Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.

Review, analyze and provide recommendations for verification and validation test data.

Provide guidance on resolving deviations associated with verification and validation activities.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required:

Bachelor’s Degree in engineering, science, or technical related field.

Engineering degree is preferred

Preferred:

5 years or more experience of experience in design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $80,700.00 – $161,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: United States
Abbott Park : AP06C

ADDITIONAL LOCATIONS: United States
Columbus : 2900 Easton Square Place

WORK SHIFT: Standard

TRAVEL: Yes, 25 % of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link – English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link – Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Expected salary: $80700 – 161300 per year

Location: Columbus, OH – Abbott Park, IL

Job date: Sun, 29 Oct 2023 22:07:16 GMT

Apply for the job now!

The post Senior Validation Quality Engineer – Nutrition – Columbus, OH/Abbott Park, IL – or any Plant location in the US appeared first on World News: Entertainment, lifestyle, Health, Technology.

Job description: About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance – reimbursement up to $10,000 annually
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Responsible for leading the validation and qualification of large-scale commercial projects for facility, utility, equipment, and system & cleaning activities. Serves as the Subject Matter Expert (SME) for industry standards and validation compliance requirements and supply support/technical knowledge for the development/refinement and implementation of validation standards. Work with site leadership to manage and create group strategy and systems, allocate resources to projects, and manage timelines for qualification projects. Will lead and provide daily direction to internal and external support for validation projects.

Relationships

Reports to the Project Director.

Essential Functions

• Serve as Lead for all large-scale validation projects while sourcing external support for commissioning and validation activities
• Develop scope of work for investment projects to include submitting and reviewing bids from externals, providing analysis, and recommendations for vendor selection
• Initiate, design, and evaluate plans for site projects, to include the planning and execution of all tasks needed to meet goals
• Execute priorities and consider long range project planning through consultation with supervisor while demonstrating good project and employee management skills
• Maintain up-to-date schedules, budgets, & risk assessments for projects as well as knowledge of validation standards and regulatory compliance requirements
• Serve as the SME for equipment qualification, laboratory equipment qualification, facility/utility qualification, control system qualification, and associated systems and procedures
• Contribute to long-term strategic development of validation program, including mentoring activities for the development of the Validation team, policies & procedures development and the development of the Validation Team & validation practices to ensure compliance
• Analyze and interpret validation data, make independent tactical decisions based on data and develop project strategies with consultation with supervisor
• Lead the preparation and execution of validation protocols, data analysis, and final reporting
• Provide validation input and direct support during regulatory inspections
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
• Implement department action plans based on the results from internal or external audits, CAPA (Corrective and Preventive Actions), and exception management processes
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

Development of People

Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Bachelor’s degree in a relevant field of study from an accredited university required
• Master’s degree in a relevant field of study from an accredited university preferred
• PMP (Project Management Professional) certification preferred
• Minimum of fifteen (15) years of experience in the pharmaceutical or biotechnology industry required
• Minimum of seven (7) years of direct supervisory experience required
• Minimum of ten (10) years of experience in proven validation experience required
• Proven background of leading medium and large-scale projects from design, through installation, commissioning, and qualification, and into commercial use required
• Strong project management skills, developing and tracking budgets and schedules for projects, and providing inputs into project risk analysis required
• Strong understanding of: Validation concepts, international cGMP regulations and other industry standards pertaining to validation, and the technical requirements for Validation and of biopharmaceutical equipment, facilities, and/or instrumentation required
• Strong work ethic (self-motivated) honesty, excellent communication skills, and the ability to work in teams-displays initiative and commitment required
• Proven experience supervising teams required
• Excellent communication skills and ability to work in teams required
• Proven validation management within an FDA and EMEA regulated production facility required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Expected salary: $10000 per year

Location: Clayton, NC

Job date: Wed, 25 Oct 2023 22:50:28 GMT

Apply for the job now!

The post Senior Project Manager – Validation – United States Sourcing Hub appeared first on World News: Entertainment, lifestyle, Health, Technology.

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Senior Project Manager – Validation – United States Sourcing Hub

Facility: Quality

Location:

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance – reimbursement up to $10,000 annually
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Responsible for leading the validation and qualification of large-scale commercial projects for facility, utility, equipment, and system & cleaning activities. Serves as the Subject Matter Expert (SME) for industry standards and validation compliance requirements and supply support/technical knowledge for the development/refinement and implementation of validation standards. Work with site leadership to manage and create group strategy and systems, allocate resources to projects, and manage timelines for qualification projects. Will lead and provide daily direction to internal and external support for validation projects.

Relationships

Reports to the Project Director.

Essential Functions

• Serve as Lead for all large-scale validation projects while sourcing external support for commissioning and validation activities
• Develop scope of work for investment projects to include submitting and reviewing bids from externals, providing analysis, and recommendations for vendor selection
• Initiate, design, and evaluate plans for site projects, to include the planning and execution of all tasks needed to meet goals
• Execute priorities and consider long range project planning through consultation with supervisor while demonstrating good project and employee management skills
• Maintain up-to-date schedules, budgets, & risk assessments for projects as well as knowledge of validation standards and regulatory compliance requirements
• Serve as the SME for equipment qualification, laboratory equipment qualification, facility/utility qualification, control system qualification, and associated systems and procedures
• Contribute to long-term strategic development of validation program, including mentoring activities for the development of the Validation team, policies & procedures development and the development of the Validation Team & validation practices to ensure compliance
• Analyze and interpret validation data, make independent tactical decisions based on data and develop project strategies with consultation with supervisor
• Lead the preparation and execution of validation protocols, data analysis, and final reporting
• Provide validation input and direct support during regulatory inspections
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes
• Implement department action plans based on the results from internal or external audits, CAPA (Corrective and Preventive Actions), and exception management processes
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

Development of People

Supervisory, ensure that reporting personnel have Individual Development Plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Qualifications

• Bachelor’s degree in a relevant field of study from an accredited university required
• Master’s degree in a relevant field of study from an accredited university preferred
• PMP (Project Management Professional) certification preferred
• Minimum of fifteen (15) years of experience in the pharmaceutical or biotechnology industry required
• Minimum of seven (7) years of direct supervisory experience required
• Minimum of ten (10) years of experience in proven validation experience required
• Proven background of leading medium and large-scale projects from design, through installation, commissioning, and qualification, and into commercial use required
• Strong project management skills, developing and tracking budgets and schedules for projects, and providing inputs into project risk analysis required
• Strong understanding of: Validation concepts, international cGMP regulations and other industry standards pertaining to validation, and the technical requirements for Validation and of biopharmaceutical equipment, facilities, and/or instrumentation required
• Strong work ethic (self-motivated) honesty, excellent communication skills, and the ability to work in teams-displays initiative and commitment required
• Proven experience supervising teams required
• Excellent communication skills and ability to work in teams required
• Proven validation management within an FDA and EMEA regulated production facility required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Expected salary: $10000 per year

Location: Clayton, NC

Job date: Thu, 26 Oct 2023 06:38:03 GMT

Apply for the job now!

The post Senior Project Manager – Validation – United States Sourcing Hub appeared first on World News: Entertainment, lifestyle, Health, Technology.