Equipment Validation Compliance Specialist
Core
Review and approve qualification protocols and reports (IQ/OQ/PQ) for equipment and systems to ensure regulatory compliance in sterile pharmaceutical manufacturing.
Role type
Equipment Validation Compliance Specialist
Builds
Qualification documentation and compliance assurance for pharmaceutical equipment and systems
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IQ/OQ/PQ validation principles, cGMP regulations, FDA/EMA validation standards, 21 CFR Part 11 compliance, risk assessment (FMEA), sterile pharmaceutical manufacturing knowledge, technical documentation review, SOP maintenance
Preferred skills
Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biotechnology, Biology, Engineering
Technologies
Microsoft Office suite
Responsibilities
Review technical documentation for equipment qualification compliance; Approve qualification protocols and reports ensuring accuracy and GMP adherence; Provide quality oversight for equipment qualification activities; Support customer and regulatory inspections with documentation; Monitor implementation of quality procedures; Maintain and update validation SOPs and documentation
Seniority
Mid-Senior, hands-on IC
