Process Engineer – Technical Services

6 hours ago

Galway, Ireland Asset Recruitment Full time

Process Engineer – Technical Services (Equipment & Projects)

About the opportunity

Join a global pharmaceutical company as a Process Engineer – Technical Services (Equipment & Projects).

This is a 12-month contract opportunity. In this role, you will be responsible for supporting the qualification and validation of manufacturing equipment, utilities, and systems, ensuring they remain in a validated state. You will collaborate with cross-functional teams, execute validation protocols, and support regulatory compliance, contributing directly to operational readiness and process excellence.

Responsibilities

- Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.

- Conduct risk assessments (e.g., FMEA) to define validation strategies and critical parameters.

- Maintain the validated condition of manufacturing equipment, clean utilities, and process support systems.

- Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.

- Support qualification of clean utilities (e.g., WFI, clean steam, compressed air, HVAC).

- Ensure proper validation of automation and control systems (SCADA, PLC, MES) as required.

- Investigate validation deviations and non-conformances, implementing corrective and preventive actions (CAPAs).

- Evaluate the impact of equipment modifications and process changes on the validated state.

- Prepare and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.

- Ensure compliance with Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.

Requirements

- Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Life Sciences.

- 5–7 years of experience in validation, equipment qualification, or technical services within a sterile injectables manufacturing.

- Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.

- Experience with validation lifecycle (URS, FAT/SAT, PQ) and computerized system validation (CSV).

- Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.

- Knowledge of data integrity principles (ALCOA+).

- Practical experience with environmental monitoring systems and cleanroom qualification.

- Knowledge of autoclave and depyrogenation tunnel operation.

- Experience with load preparation, thermocouple calibration/placement, and handling biological indicators.

Preferred

- Familiarity with endotoxin spiking procedures.

- Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.

- Knowledge of Process Analytical Technology (PAT) and digital validation tools.

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