A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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.
As the Validation Engineering Manager at our Carlsbad Gene Therapy and Viral Vector Manufacturing site, you will be responsible for leading all aspects of validation and calibration engineering activities, including defining, authoring, executing, and closing validation qualification testing for manufacturing process equipment and instruments, lab equipment, and computer systems. The Validation Engineering Manager will ensure compliance with the established SOPs, cGMP, and all regulatory agencies and provide leadership at all levels of the organization to support production of drug substance and drug products for gene therapy and oncology applications
Who You Are:
- BS degree in a scientific or engineering discipline or equivalent. MS preferred.
- Minimum of 10 years of experience in validation engineering.
- Previous leadership/supervisory experience is required.
- Expert knowledge of utilities, systems, and equipment in support of biopharmaceutical manufacturing processes, including HVAC, Water Systems, WFI, Autoclave/Steam Sterilization Systems, Bioreactor Systems, Chromatography Systems, Controlled Temperature Units (CTUs), and Computer Systems.
- Ability to clearly communicate project objectives, timelines, progress updates and project risks to team members and stakeholders.
- Strong foundation in Lean Manufacturing and Continuous Improvement.
- Experienced in developing and driving comprehensive quality metrics, including Key Performance Indicators (KPIs).
- Familiar with regulatory requirements and industry standards, ensuring compliance with cGMP, ISO, FDA, and EMA requirements.
- Ability to work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
- Proven ability to establish direction and obtain commitment to ensure that projects are completed on time and on budget, streamlining processes to maximize productivity.
- Excellent organizational, analytical, and technical writing skills.
- Self-directed and detail-oriented, with superior skills in planning, organizing, and communicating project tasks across multidisciplinary teams.
- Experienced in providing technical advice and support for internal and external interactions, including client and regulatory audits/inspections.
- Capable of working independently as well as in a team.
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 https://jobs.vibrantm.com
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.