Hybrid Senior Staff Program Manager, Commissioning and Qualification

at Thermo Fisher Scientific

• Job title: Senior Staff Program Manager, Commissioning and Qualification
• Job type: Full Time
• Experience level: Senior
• Salary: $150,000 - $170,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Plainville, United States

About the role

• Sr. Staff Program Manager engaging with PSG sites to ensure compliance with validation policies. Managing complex projects within the pharmaceutical sector to improve safety and efficiency.

Responsibilities

• 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