Job Description
Technical Services Engineer required by pharmaceutical company based in Co. Galway.
As part of the Technical Services function the Technical Services Engineer – Product/Process will be responsible for supporting the development & optimization of aseptic pharmaceutical manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives as well as technical transfer and New Product Introductions.
Responsibilities
Process Development & Optimization:
1. Design, develop, and optimize pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
2. Conduct and document process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
3. Lead investigations into deviations, non-conformances, and root cause analyses.
4. Support scale-up, tech transfer, and commercialization of new products.
Validation & Compliance:
5. Lead the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
6. Generation of change controls aligned with site procedures to support product/process changes
7. Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
8. Support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.
Manufacturing Support & Troubleshooting:
9. Provide on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
10. Collaborate with production and quality teams to ensure consistent process performance.
11. Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).
NPI, Technical Transfer & Scale-Up:
12. Support technology transfers between development, pilot, and commercial-scale manufacturing.
13. Work closely with R&D, and Site Operations teams to ensure smooth process transitions.
14. Define critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up.
Continuous Improvement & Innovation:
15. Identify and implement process improvements using Lean, Six Sigma, and other problem-solving methodologies.
16. Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
17. Support cost-reduction initiatives while maintaining quality and compliance.
Perform other duties as assigned
Requirements:
18. Education: Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
19. Experience: 2–7 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
20. Experience in sterile injectables or biologics manufacturing.
21. Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
22. Experience with process validation (PPQ), DOE, and statistical process control (SPC).
23. Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
24. Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
25. Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, and lyophilizers, modes of operation, critical process parameters etc.
26. Good knowledge of aseptic behaviours, filter integrity testing, single use systems etc.
27. Proficiency in data analysis tools (e.g., Minitab) and process modeling software.
28. Six Sigma or Lean Manufacturing certification.
29. Experience with automation systems (e.g., SCADA, MES).
30. Knowledge of process analytical technology (PAT).