Contract Validation Engineer

4 weeks ago

Galway, Galway, Ireland Quanta Consultancy Services Ltd Full time
Contract Validation Engineer - Ireland - 9 Months Contract

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland? Our esteemed client is looking for a Contract Validation Engineer to join their team in their existing manufacturing facility in Ireland.

The facility is responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Contract Validation Engineer to help maintain manufacturing operations.

Responsibilities:

1. Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
2. Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
3. Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
4. Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
5. Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
6. Support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
7. Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
8. Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
9. Support audits and regulatory inspections by providing validation data and technical justifications.
10. Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.

Requirements:

1. Education: Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
2. Extensive experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
3. Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
4. Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
5. Experience with validation life cycle approach (URS, FAT/SAT, PQ).
6. Knowledge of data integrity (ALCOA+ principles) and computerised system validation (CSV).
7. Familiarity with environmental monitoring systems and clean-room qualification.
8. Strong analytical and problem-solving skills.
9. Excellent documentation and technical writing abilities.
10. Effective communication and cross-functional collaboration.

If this role is of interest to you, please apply now

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