Supervisor - Engineering, Validation
Core
Lead validation programs (commissioning, qualification, computer system validation) for a biologics manufacturing facility to ensure FDA compliance and maintain validated systems.
Role type
Senior IC validation supervisor (pharmaceutical manufacturing)
Builds
Validated manufacturing systems and processes for biologics
Domain
Biopharmaceuticals / Biologics manufacturing
Required skills
Validation lifecycle management, CQV (Commissioning, Qualification, Validation), Change Control impact assessments, requalification programs, protocol/report writing, cGMP, FDA/ICH/EMA regulations
Preferred skills
Biologics manufacturing, cell therapy/gene therapy environments, CDMO experience
Technologies
Single-use systems, GPEx® technology
Responsibilities
Lead validation team, maintain Validation Master Plans, review/approve protocols and reports, support CQV activities, manage requalification, participate in audits, drive continuous improvement
Seniority
Senior, hands-on IC with leadership