Hybrid Senior Staff Program Manager, Commissioning and Qualification – Steriles

at Thermo Fisher Scientific

• Job title: Senior Staff Program Manager, Commissioning and Qualification – Steriles
• Job type: Full Time
• Experience level: Senior
• Salary: $143,000 - $180,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Plainville, United States

About the role

• Sr. Staff Program Manager overseeing commissioning and qualification at Thermo Fisher Scientific, supporting global engineering teams and ensuring compliance with regulatory standards.

Responsibilities

• Ensuring site adherence to global validation policies and procedures
• High level support for Capital Project validation within the network
• 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
• Commissioning, Qualification and Validation SME

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
• Experience with risk management and mitigation strategies
• Ability to lead and influence in a matrix and global environment effectively
• Willingness to travel up to 20% as required, domestic/international
• Working knowledge of deviation and quality record platform (i.e. TrackWise)
• Experience qualifying systems using Kneat or other paperless validation tools is highly preferred.
• Ability to manage multiple high-priority initiatives simultaneously
• Experience working with global, geographically dispersed teams

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