Manufacturing Validation Engineer III
Core
Lead complex validation projects for pharmaceutical manufacturing equipment, processes, facilities, and computer systems to ensure regulatory compliance and product quality.
Role type
Manufacturing Validation Engineer
Builds
Validated manufacturing equipment, utilities, cleaning processes, and computer systems for pharmaceutical/biotech clients
Domain
Pharmaceutical manufacturing / Biotechnology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocols (IQ/OQ/PQ), Risk assessment methodologies, Statistical analysis, cGMP regulations knowledge, Root cause analysis, Technical writing
Preferred skills
Engineering or Life Sciences degree, Experience in regulated industry, Cross-functional team leadership
Technologies
MS Office, Statistical packages, Validation systems
Responsibilities
Lead complex validation projects for equipment, processes, expansion facilities, and computer systems; Create validation documentation IQ/OQ/PQ, establishing sampling plans and equivalency studies; Leverage risk-based approach to develop validation plans; Collaborate with cross-functional teams to maintain GMP standards; Contribute to continuous improvement initiatives and support audits; Ensure product quality and regulatory compliance across operations
