Thermo Fisher Scientific · 4 hours ago
Sr. Staff Program Manager, Commissioning and Qualification
United States
Full-time
Remote
Senior Level, Lead/Staff
$150K/yr - $170K/yr
10+ years expThermo Fisher Scientific is a global leader in serving science, dedicated to making the world healthier, cleaner, and safer. The Sr. Staff Program Manager will engage with and support the PSG network, providing oversight for commissioning, qualification, and validation processes across various sites. This role requires in-depth knowledge of manufacturing processes, regulations, and quality management principles to ensure compliance and successful project outcomes.
Research
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
Qualification
Required
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
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
Strong communication and presentation skills at all organizational levels
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)
Ability to manage multiple high-priority initiatives simultaneously
Preferred
Audit experience strongly preferred
Experience qualifying systems using Kneat or other paperless validation tools is highly preferred
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
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
Company data provided by crunchbase