Technical Services Engineer – Product/Process (Contractor)
Location: Galway, Ireland. Contract duration: 12 months. The role focuses on supporting the development and optimisation of aseptic pharmaceutical manufacturing processes, ensuring regulatory compliance, and driving continuous improvement initiatives.
Responsibilities
* Design, develop and optimise pharmaceutical manufacturing processes, ensuring robust, scalable and cost‑effective production.
* Conduct and document process risk assessments (FMEA) and implement risk‑mitigation strategies.
* Lead investigations into deviations, non‑conformances and root cause analyses.
* Support scale‑up, tech transfer, alternate source qualification and NPI activities including study design, protocol generation and reporting.
* Prepare and execute Process Validation protocols (PPQ), Continued Process Verification and generate change controls aligned with site procedures.
* Ensure all process changes comply with cGMP, FDA, EMA and other regulatory requirements and assist regulatory filings (CMC sections).
* Provide on‑floor technical support for routine manufacturing operations, deviations and process issues.
* Analyse process data trends to drive continuous improvement and reduce variability in critical quality attributes.
* 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, supporting cost‑reduction initiatives.
Requirements
* Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology or a related field.
* 3–7 years of experience in pharmaceutical manufacturing, process engineering or technical services.
* At least 2 years’ experience in sterile injectables or biologics manufacturing.
* Six Sigma or Lean Manufacturing certification.
* Experience with automation systems (e.g., SCADA, MES) and process analytical technology (PAT).
* Strong analytical and problem‑solving skills; excellent communication and cross‑functional collaboration.
* Ability to manage multiple projects in a fast‑paced environment.
* Strong knowledge of aseptic processing, terminal sterilisation, lyophilisation, process validation (PPQ), DOE, SPC.
* Proficiency in cGMP, Annex 1, FDA, EMA, ICH guidelines for sterile products and generation of cGMP documentation.
* Practical experience with filling machines, isolators, autoclaves, depyrogenation tunnels, lyophilisers and related equipment.
* Proficiency in data‑analysis tools (Minitab) and process modelling software.
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