VALIDATION ENGINEER IV
Core
Lead complex validation and qualification initiatives for cGMP pharmaceutical and medical device contract manufacturing across multiple facilities.
Role type
Senior IC Validation Engineer (IV)
Builds
Validated equipment, utilities, processes, and facilities for biopharma clients
Domain
Biopharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP validation strategies, risk assessment and mitigation, change control management, protocol development, regulatory compliance (FDA/ICH/ISO), technical writing, cross-functional collaboration, mentoring
Preferred skills
Thermal characterization, vacuum physics, heat and mass transfer, formulation, aseptic filling, lyophilization, sterilization, experience with regulatory inspections
Technologies
Microsoft Office (Word, Excel, PowerPoint, Project)
Responsibilities
Author validation plans and specifications, review and approve lifecycle documentation, provide direction on equipment/process change control, perform periodic system reviews, define validation strategies, mentor colleagues, execute validation protocols, propose corrective actions
Seniority
Senior, hands-on IC with leadership responsibilities
