Senior Staff Program Manager, Commissioning and Qualification
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Hybrid
Location: Plainville • Massachusetts • Montana • United States
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Salary
💰 $150,000 - $170,000 per year
Job Level
About the role
- Engage with and support the sites within the PSG network
- Ensure site adherence to global validation policies and procedures
- Provide support for regulatory/customer audits, documents and engagements as needed to foster successful business outcomes
- Support sites as needed with pre-inspection readiness within CQV space
- Be viewed as a subject matter expert for commissioning and qualification programs, regulations, and requirements
Requirements
- Bachelor's Degree in Engineering or related field
- 10+ years of related experience in the Pharmaceutical or related industry including experience in validation, engineering, operations, program and project management
- Extensive knowledge of full validation lifecycle requirements for Steriles Manufacturing, Biologics, Clean Utilities and Support Services
- Audit experience strongly preferred
- Advanced knowledge of CQV for pharmaceutical equipment and systems (e.g Filling lines, Isolators, Autoclaves, Lyophilizers, Single Use Bioreactors and Mixers, WFI, Clean Steam, Process Gases, and ancillary equipment)
- Proven track record leading medium to large-scale capital projects through commissioning and qualification
- Advanced knowledge of applicable regulatory requirements (FDA, EMA, WHO, Annex 15, ISO, etc.) related to commissioning, qualification and validation
- Strong analytical and problem-solving capabilities
- Willingness to travel up to 20% as required, domestic/international
- Working knowledge of deviation and quality record platform (i.e. TrackWise)
Benefits
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
validationcommissioningqualificationprogram managementproject managementCQVSteriles ManufacturingBiologicsClean Utilitiesregulatory requirements
Soft skills
analytical skillsproblem-solvingcommunicationleadership