We are looking for a Validation Engineer who's focus will be supporting equipment / utility / environmental qualification onsite.
Responsibilities:
- Routine re-qualification ownership:
- CTUs: periodic temperature mapping (Fridges, Freezers, Coldrooms Incubators)
- Classified areas and utilities re-qualification. (Process GAsses CO2, O2, Air).
- Downflow booths, BSCs, LAF, Fume Hood - airflow patterns, velocities, filter integrity, containment checks.
- Requalification of autoclaves. (EN285).
- Select process equipment: periodic re-qualification based on criticality (e.g., parts washers, Vi-Cells., as applicable).
- New equipment introductions:
- Author Master Validation Plans; input to URS alignment and risk assessments to scope IQ/OQ/PQ.
- Execute/oversee protocols, validation discrepancies.
- Validation Summary Reports.
- Change control/Lifecycle:
- Participate in engineering change assessments; judge impact of automation/mechanical changes along with area SMEs.
- Maintain VMP, equipment files, traceability; ensure data integrity/inspection readiness
Skills, Attributes & Experience:
- Minimum of 4 years + experience working in a Validation role within Pharmaceuticals or Medical Device.
- Strong equipment/utility qualification experience.
- Hands-on with temperature mapping, cleanroom and utilities re-qualification.
- Ownership mindset with high drive and accountability - "run it like you own it," proactively solving problems and pushing validation activities to completion.
