Experienced Validation Engineer Softgels Tilburg
Core
Plans, implements, and documents validation/qualification activities for equipment, cleaning, and processes in a softgel capsule production environment.
Role type
Validation Engineer (Pharmaceutical Manufacturing)
Builds
Validated equipment, systems, and processes for softgel capsule production
Domain
Pharmaceutical manufacturing / Softgel capsule production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Commissioning and Validation expertise, User Requirement Specifications (URS) drafting, IQ/OQ/PQ protocol design and execution, Cleaning Validation, Continued Process Verification (CPV), audit support (SME), regulatory compliance knowledge
Preferred skills
Experience in highly regulated environments, project leadership, change management
Technologies
GMP, cGMP, IQ/OQ/PQ, CPV, URS
Responsibilities
Design and qualify new equipment and systems, draft and perform implementation of validation protocols, write cleaning and CPV protocols, provide validation technical support, review and amend validation procedures and master plans, support internal and external audits
Seniority
Mid-level, hands-on IC
