A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Sr. Validation Engineer
This position is responsible for leading validation projects and managing consultants. Sr. Validation Engineer will be a senior member of the validation team developing, reviewing, and executing validation activities, and ensuring that the qualification/validation activities are consistent with user's/manufacturer's requirements and site quality standards. This role will be responsible for validation activities such as:
- Lead site expansion validation project manage consultants and co-ordinate project schedule.
- Create and review validation documentation like Validation Protocols, Reports, FAT/SAT, risk assessments, design qualifications and act as Validation SME for cross-functional meetings.
- Perform risk assessments/FMEAs for equipment.
- Act as technical lead for a cross-functional project and regularly interfaces with other groups to coordinate activities ensuring effective and clear communications.
- Interact with cross-functional groups ensuring effective communication.
- Ability to effectively solve technical problems and form solutions/plans to mitigate issues independently.
- Work with equipment vendors to define requirements and understand functional specifications.
- Represent validation program during audits and inspections.
- Master's Degree in Biology, Chemistry or related science discipline with 8+ years of experience in Biologics, Pharma, Device or Biotech OR a bachelor's degree in Biology, Chemistry or related science discipline with 10+ years of experience in Biologics, Pharma, Device or Biotech.
- 4+ years of experience in leading big projects, managing consultant and project schedule.
- 6+ years of experience in qualification for lab and/or manufacturing equipment and utilities, re-qualification, periodic reviews and Asset Management (RAM).
- 6+ years of experience in qualification of Single use Bioreactors, TCUs, automated fillers, Isolator and temperature mapping of CTUs.
- 6+ years of experience of writing risk assessments per Quality Risk Management concepts, creating plans, protocols, reports, FAT/SAT and SOP's for validation reports.
- 4+ years in managing consultants, Reviewing TOP and commissioning packages and validation documents.
- Experience in Biologic manufacturing facility and site expansion.
- Experience in viral vector CMO.
- Experience with new facilities to support validation project from the site construction.
- Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program.
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.
Job Requisition ID: 215497
Career Level: E - Professional (10+ years)
Working time model: full-time
This job has expired.