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.