Technical Services Engineer - Equipment & Projects (Contractor)
CareerWise Recruitment is recruiting for a Galway based client for the position of Technical Services Engineer – Equipment & Projects (Contractor).
Location: Galway, Co. Galway (Head office)
Employment type: Fixed term
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.
* 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.
* Investigate validation deviations and non‑conformances, implementing corrective and preventive actions (CAPAs).
* Assess the impact of equipment modifications and process changes on validated state.
* Collaborate with Manufacturing, Quality, and Engineering teams to ensure smooth execution of validation activities.
* Implement Lean and Six Sigma principles to optimize validation processes and reduce qualification cycle times.
* Support adoption of new technologies in aseptic processing, automation, and real‑time monitoring.
* Evaluate requalification strategies and periodic review programmes to ensure compliance and efficiency.
Qualifications
* Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
* 5–7 years of experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
* Knowledge/familiarity of endotoxin spiking procedure – could help with micro‑resource shortage with respect to depyrogenation tunnel qualification.
* Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
* Familiarity with Process Analytical Technology (PAT) and digital validation tools.
* Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
* Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
* Experience with validation lifecycle approach (URS, FAT/SAT, PQ).
* Knowledge of data integrity (ALCOA+ principles) and computerized system validation (CSV).
* Practical familiarity with environmental monitoring systems and cleanroom qualification.
* Knowledge of autoclave and depyrogenation tunnel operation.
* Knowledge of load preparation – thermocouple calibration and placement.
* Handling of biological indicators.
Contact
please call Tom Devaney today for further information on 091‑758771 or email: tdevaney@careerwise.ie
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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