Full job descriptionWalker Cole International is partnering exclusively with a well-established pharmaceutical manufacturer to appoint a Qualification Engineer into their Project Engineering function.
Reporting to the Qualification Manager, you’ll be responsible for ensuring equipment, facilities and utilities meet regulatory, operational and performance requirements - covering the full qualification lifecycle from URS through to IQ, OQ, PQ and Periodic Review.
What the Qualification Engineer will Be Doing:
*Planning, developing and executing qualification documentation (URS, TRM, DQ, IQ, OQ, PR) for equipment, utilities and facilities, liaising with vendors for on-site testing
*Working cross-functionally with Engineering, Manufacturing, Quality, Maintenance and MS&T to deliver qualification activities, including Computerised System Validation (CSV)
*Providing technical expertise and support during regulatory audits and inspections
*Using the site QMS to identify, investigate and resolve issues - including CAPAs, Change Controls and Deviations - and ensuring all documentation is audit-ready
What the Qualification Engineer should have:
*Solid experience in a qualification, validation or project engineering role within a GMP-regulated manufacturing environment
*Confidence drafting and reviewing qualification protocols and technical documentation, with strong attention to detail
*Comfortable liaising directly with vendors and coordinating on-site qualification testing
*A collaborative approach, with experience working across Engineering, Quality, Manufacturing and MS&T functions
Qualification Engineer | URS | IQ | OQ | PQ | DQ | TRM | Periodic Review | GMP | CSV | CAPA | Change Control | Deviations | Validation | Vendor Management | Technical Documentation | Audits | Inspections | QMS | Equipment Qualification
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