Contract Validation Engineer
- Ireland, West
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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 a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for an Contract Validation Engineer to help maintain manufacturing operations.
Responsibilities:
- Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
- Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
- Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
- Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
- Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
- Support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
- Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
- Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
- Support audits and regulatory inspections by providing validation data and technical justifications.
- Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.
- Education: Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
- Extensive experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
- Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
- Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
- Experience with validation life cycle approach (URS, FAT/SAT, PQ).
- Knowledge of data integrity (ALCOA+ principles) and computerised system validation (CSV).
- Familiarity with environmental monitoring systems and clean-room qualification.
- Strong analytical and problem-solving skills.
- Excellent documentation and technical writing abilities.
- Effective communication and cross-functional collaboration.
#LI-CY2
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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