LSC have a great contract opportunity for a Validation Engineer in a Biologics Drug substance manufacturing facility in Cork.
The Engineering Validation Associate reports to the Senior Commissioning, Qualification and Validation (CQV) Manager; day-to-day technical direction may be delegated to the Engineering Validation Team Lead as required.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The role is responsible for delivering validation activities in a GxP-regulated environment, including commissioning, qualification and validation of laboratory systems, new manufacturing equipment/processes, utilities and facilities, and changes to existing equipment/processes in line with the site's validation lifecycle approach (ASTM E2500 / ICH Q8-Q10 / EU GMP Annex 15).
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation (including Continued Process Verification) programs.
- Execute (protocol generation, execution, discrepancy/deviation resolution, and final package preparation) validation activities related to the various validation disciplines, e.g. FUE Qualification, Computerized System Validation (CSV/CSA), Cleaning Validation, Sterilization/Aseptic Process Validation, New Product Introductions and Change Control.
- Develop validation plans and requirements/traceability documentation (URS, risk assessments, traceability matrices) for specific system implementation projects.
- Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
- Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs within the site quality management system, ensuring on-time closure.
- Maintain equipment and systems in a validated state through periodic review, requalification and management of the re-validation schedule.
- Ensure data integrity (ALCOA+) requirements are met across validation documentation and computerized systems, including audit trail review, access control and electronic records/signatures (21 CFR Part 11 / EU GMP Annex 11).
Education & Experience
- Level 7/8 degree in Engineering, Science or a related technical discipline.
- 2-5 years' validation, CQV or equivalent experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Working knowledge of EU GMP, FDA regulations and validation lifecycle methodologies.
- Experience authoring and executing qualification protocols (IQ/OQ/PQ) and managing quality system records (change controls, deviations, CAPAs).
- Strong technical writing, problem-solving and cross-functional communication skills.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Siobhan Cummins on 021 4777 329 to discuss this new role in detail or apply directly via this advert
