Role Overview
The successful candidate will lead process development and optimisation activities for [drug substance / drug product / biologics] manufacturing, working cross-functionally with Manufacturing, Quality, Validation, and Regulatory Affairs to bring processes from development through to robust, commercial-scale production. This is a hands-on, technically demanding role suited to a senior engineer who can add value quickly with minimal ramp-up time.
Key Responsibilities
- Lead process development, characterisation, and optimisation activities for [assigned product/process area], applying sound engineering and scientific principles.
- Design, execute, and analyse process development studies and experiments, including DoE (Design of Experiments) methodologies where applicable.
- Support technology transfer of new products/processes from development or another manufacturing site into the Galway facility, ensuring robust, scalable, and compliant processes.
- Author and review technical documentation, including process development reports, risk assessments, protocols, and process validation documentation.
- Identify and troubleshoot process deviations and manufacturing issues, applying root cause analysis and driving corrective/preventive actions.
- Collaborate with Manufacturing, Quality, Validation, Regulatory Affairs, and Automation teams to ensure successful process implementation.
- Support regulatory submissions and inspections with technical process data and rationale as required.
- Drive continuous improvement initiatives to enhance process robustness, yield, and efficiency.
- Provide technical mentorship and guidance to junior engineering team members as required.
- Ensure all work is conducted in compliance with EU GMP, HPRA requirements, and site EHS standards.
Essential Qualifications & Experience
- Degree (or higher) in Chemical Engineering, Biochemical Engineering, Process Engineering, or a related scientific/engineering discipline.
- Substantial process development/engineering experience within pharmaceutical, biopharmaceutical, or biotech manufacturing.
- Strong working knowledge of EU GMP and HPRA regulatory requirements as they apply to process development and technology transfer.
- Demonstrable experience with process characterisation, scale-up, and/or technology transfer activities.
- Proficiency in statistical/DoE tools (e.g. JMP, Minitab) and strong technical report-writing skills.
- Available to start within a short notice period, given the contract nature of the role.
Desirable Criteria
- Experience specific to the site's product type (e.g. biologics/large molecule, sterile/aseptic fill-finish, oral solid dose, or drug-device combination products).
- Six Sigma / Lean qualification, or demonstrable continuous improvement project leadership.
- Prior contract/interim experience in a similar process development capacity.
- Experience with single-use technology, continuous manufacturing, or other advanced processing platforms, where relevant to the site.
- Direct experience supporting HPRA or FDA regulatory inspections.
Person Specification
- Strong technical and analytical problem-solving skills, with sound engineering judgement.
- Self-sufficient and effective from day one, able to integrate quickly into an established engineering team.
- Excellent cross-functional communication skills, comfortable presenting technical findings to varied audiences.
- Detail-oriented and methodical, particularly around documentation and regulatory compliance.
- Resilient and adaptable, comfortable working in a fast-moving, project-driven environment.