Technical Services Engineer – Equipment & Projects
Contractor required by CareerWise Recruitment for our Galway‑based client. The Technical Services Engineer – Equipment & Projects will support the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing to ensure they remain in a validated state. This role involves developing and executing validation protocols (IQ, OQ, PQ), supporting regulatory compliance, and collaborating with cross‑functional teams to ensure operational readiness.
The Role
* Equipment Qualification & Validation: develop, execute, and review IQ, OQ, and PQ protocols for sterile manufacturing equipment; ensure compliance with cGMP, FDA, EMA, and Annex 1; perform risk assessments; maintain validated state of equipment and support systems.
* Sterile Manufacturing Equipment & Systems: qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, RABS systems, and automation/control systems.
* Regulatory & Compliance Support: author and review validation documentation, support audits and inspections, ensure adherence to Annex 1, ICH Q9, ICH Q10, FDA Process Validation Guidance.
* Deviation Management & Change Control: investigate deviations, implement CAPAs, assess impact of modifications, collaborate with quality and engineering teams.
* Continuous Improvement & Technology Upgrades: implement Lean and Six Sigma, support adoption of new technologies, evaluate requalification strategies.
Requirements
* 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 with endotoxin spiking procedure.
* Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
* Familiarity with Process Analytical Technology (PAT) and digital validation tools.
* Technical Skills:
o Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
o Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
o Experience with validation lifecycle approach (URS, FAT/SAT, PQ).
o Knowledge of data integrity (ALCOA+ principles) and CSV.
o Practical familiarity with environmental monitoring systems and cleanroom qualification.
o Knowledge of autoclave and depyrogenation tunnel operation.
o Knowledge of load preparation – thermocouple calibration and placement.
o Handling of biological indicators.
Location: Galway, County Galway, Ireland. Employment type: Contract.
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