Freelance Validation Engineer x 2 - Ireland & Belgium
Job Title: Freelance Validation Engineer
Location: Ireland and Belgium
Contract Duration: 12 Months
Job Description: As Senior Validation Engineer/ PQ Specialist, and as part of an integrated project team, you drive the PQ preparation and execution activities of the project ensuring they are completed in accordance with system requirements, specifications, quality attributes and project procedures/ guidelines.
Scope:
- Clean Utilities (water, gas, air, steam, decontamination station)
- Facility Environmental Monitoring (classified area PQ)
- Temperature control units (fridge, freezer, incubator, thawing cabinets, cold rooms, ambient areas)
- Cleaning (Parts Washer cleaning cycle, CHT and DHT)
- Sterilisation (Autoclave sterilisation cycle, SHT)
- Vial Filling (Filling accuracy under Grande A)
- Decontamination (VHP isolator, H2O2 classified areas)
- Automation (CSV)
- Media Simulation/ Media Fill (APS)
- Process Confirmation Run (Clinical Manufacturing): Water batch, Mock-up, Engineering runs.
Accountability's:
- Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs.
- Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
- Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
- Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities. Write and coordinate approval of change controls related to technical modifications.
- Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
- Establish and monitor validation KPIs.
- Review handover of equipment / systems from suppliers and or other project stakeholders.
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