Technical Services Engineer – Equipment & Projects

Technical Services Engineer – Equipment & Projects Contractor required by CareerWise Recruitment for our Galway based client. As part of the Technical Services function the Technical Services Engineer – Equipment & Projects will be responsible for supporting the qualification of pharmaceutical equipment, utilities, and systems used in sterile injectable manufacturing are qualified and maintained 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 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.

Sterile Manufacturing Equipment & 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.

Regulatory & Compliance Support:

• 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.

Deviation Management & Change Control:

• 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.

Continuous Improvement & Technology Upgrades:

• 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 programs to ensure compliance and efficiency.

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 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.
• Technical Skills:
• 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