Engineering Validation Associate

LSC, Life Science Consultants; Ireland; On-site; EUR 55,000 - 75,000; Full time

Job summary

LSC, Life Science Consultants is seeking a Validation Engineer for a Biologics Drug Substance facility in Cork on a contract basis. The role reports to the CQV Manager and may receive direction from the Team Lead.

The candidate will deliver validation activities in a GxP environment, including commissioning, qualification, and validation of laboratory systems, new manufacturing equipment, utilities and processes, following ASTM E2500 / ICH Q8-Q10 / EU GMP Annex 15 guidance.

Qualifications

• 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/biotech 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.

Responsibilities

• Deliver validation activities in a GxP environment, including commissioning, qualification and validation of laboratory systems, new manufacturing equipment/processes, utilities and facilities.
• Develop validation plans and traceability documentation (URS, risk assessments, trace matrices) for system implementations.
• Support site validation policies via site validation master plans, SOPs and guideline documents.
• Prepare and track change requests, deviations, quality events and CAPAs to closure.
• Maintain equipment and systems in a validated state with requalification and re-validation scheduling.
• Ensure data integrity (ALCOA+) in validation documentation and computerized systems, including audit trails and 21 CFR Part 11/EU GMP Annex 11.

Skills

Analytical Instrument Qualification

FUE Qualification

Process Validation

CSV/CSA

Cleaning Validation

Sterilization/Aseptic Validation

New Product Introductions

Change Control

ALCOA+ / Data Integrity

Education

Level 7/8 degree in Engineering, Science or related technical discipline

Tools

IQ/OQ/PQ protocols

Job description

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!