Process Validation Manager

Posted 02 Jun 2020

Carlsbad, California - United States

Req Id 206781


A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a Process Validation Manager who will be responsible for all aspects of the Process Validation Program. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work with internal and external stakeholders to manage complex timelines, meet customer expectations, and develop a best-in-class Process Validation organization. This position will oversee the teams performing Process Characterization, Process Performance Qualification (PPQ), and Continued Process Verification. This role is responsible for developing a comprehensive Process Validation program and strategy that meets current compliance requirements.

  • Lead the overall Process Validation Program to enable client projects to move from clinical to commercial production.
  • Compile and regularly update Process History File.
  • Work cross-functionally with the Manufacturing, Process Development, Engineering, and Quality teams as well as external clients to assess process risks and identify critical process parameters.
  • Define and plan process characterization work, write process characterization protocols, drive execution, and write reports.
  • Work with external clients to ensure comprehensive Process Design Reports (e.g. Process Justification Report (PJR)) ranking process parameters and quality attributes including definition of specifications and ranges.
  • Work cross-functionally to ensure that facility, equipment, and raw material qualification activities are defined and executed.
  • Write PPQ protocols, compile all data from PPQ runs, and write final PPQ report.
  • Manage Continued Process Verification program and track production data; coordinate data review sessions as well as review of process monitoring reports and Annual Product Review with client.
  • Provide technical support during client and regulatory agency site audits as needed.
  • Communicate effectively with cross-functional teams including Technical Operations, site leadership, Manufacturing, Process Development, Quality, and other internal and external network partners.


Who You Are:

Basic Qualifications:

  • Master’s, or PhD in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field.
  • Minimum of 8 years process development, engineering and/or manufacturing experience required. CMO experience is a plus.
  • Minimum of 4 years of leadership/supervisory experience; responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance.
  • Experience with Process Characterization/Validation, cGMP manufacturing, and Quality Systems within a regulated manufacturing environment.


Preferred Qualifications: 

  • Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems.
  • Experience with upstream and downstream bioprocessing unit operations.
  • Strategic planning/design, tracking, time and priorities management.
  • Innovative approach to problem-solving and integrated view of business/scientific issues.
  • Excellent computer, verbal, and written communication skills.
  • Experience with Lean Manufacturing and Continuous Improvement concepts.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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