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

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

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

Senior Staff Program Manager, Commissioning and Qualification – Steriles

Key skills