Program Manager driving growth for Berkadia’s BeEngaged startup accelerator. Overseeing program design, marketing, and strategic insights with a focus on collaboration and execution.
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Hybrid Senior Staff Program Manager, Commissioning and Qualification – Steriles
Posted last month
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
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