Senior Pharmaceutical Commissioning Qualification Validation Engineer
Core
Develop documentation, write and execute protocols, and generate summary reports for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Role type
Senior pharmaceutical commissioning, qualification, and validation (CQV) engineer
Builds
Commissioning, Qualification, and Validation documentation and execution for Life Sciences clients
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance (FDA/cGMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Protocol writing and execution, Field verification, Summary report development, cGMP leadership, Technical troubleshooting, Project planning and coordination, Team direction, Life science manufacturing process knowledge (biotech, aseptic, fill/finish, OSD, Gene Therapy), FAT/SAT execution, URS review, P&ID interpretation, IQ/OQ/PQ generation
Preferred skills
Baseline Guide 5 familiarity, Building automation knowledge, Utilities (WFI, RO, HVAC) expertise
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Develop CQV documentation for facilities, utilities, and equipment; Execute field verification and system walkdowns; Plan and coordinate CQV activities; Direct small teams in document development; Manage C&Q documentation lifecycle from SLIA to OQ completion; Support onsite/offsite activities including FATs, SATs, and IQ/OQ/PQ executions
Seniority
Senior, hands-on IC with team direction
