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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:
* Design, develop, and optimize pharmaceutical manufacturing processes, ensuring robust, scalable, and cost-effective production.
* Conduct and document process risk assessments (e.g., FMEA) and implement risk-mitigation strategies.
* Lead investigations into deviations, non-conformances, and root cause analyses.
* Support scale-up, tech transfer, and commercialization of new products.
Validation & Compliance:
* Lead the preparation and execution of Process Validation (PV) protocols (e.g., PPQ) and Continued Process Verification (CPV).
* Generation of change controls aligned with site procedures to support product/process changes
* Ensure all process changes comply with cGMP, FDA, EMA, and other regulatory requirements.
* Support regulatory filings (e.g., CMC sections of regulatory filings) with process data and technical justifications.
Manufacturing Support & Troubleshooting:
* Provide on-the-floor technical support for routine manufacturing operations, deviations, and process issues.
* Collaborate with production and quality teams to ensure consistent process performance.
* Analyze process data trends to drive continuous improvement and reduce variability in critical quality attributes (CQAs).
NPI, Technical Transfer & Scale-Up:
* Support technology transfers between development, pilot, and commercial-scale manufacturing.
* Work closely with R&D, and Site Operations teams to ensure smooth process transitions.
* Define critical process parameters (CPPs) and critical quality attributes (CQAs) for robust transfer and/or scale-up.
* Identify and implement process improvements using Lean, Six Sigma, and other problem-solving methodologies.
* Evaluate and introduce new technologies to enhance efficiency, reduce waste, and improve yield.
* Support cost-reduction initiatives while maintaining quality and compliance.
Perform other duties as assigned
Requirements:
* Education: Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
* Experience: 2–7 years of experience in pharmaceutical manufacturing, process engineering, or technical services.
* Experience in sterile injectables or biologics manufacturing.
* Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
* Experience with process validation (PPQ), DOE, and statistical process control (SPC).
* Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.
* Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
* Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, and lyophilizers, modes of operation, critical process parameters etc.
* Good knowledge of aseptic behaviours, filter integrity testing, single use systems etc.
* Proficiency in data analysis tools (e.g., Minitab) and process modeling software.
* Six Sigma or Lean Manufacturing certification.
* Experience with automation systems (e.g., SCADA, MES).
* Knowledge of process analytical technology (PAT).
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