Senior Process Development Engineer — Pharmaceutical Manufacturing, Galway (Contract)

Myn; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Myn in Galway seeks an experienced process development engineer to lead cross‑functional activities from development to robust commercial production. The role is hands‑on, technically demanding and requires rapid impact with minimal ramp‑up time.

The candidate should have extensive pharma process development experience, strong DoE and statistical skills, and a proven track record in technology transfer and regulatory documentation. EU GMP/HPRA compliance is essential.

Qualifications

• Degree in Chemical Engineering, Biochemical Engineering, Process Engineering or related field.
• Extensive process development/engineering experience in pharma/biopharma/biotech.
• Strong knowledge of EU GMP and HPRA for process development and tech transfer.
• Proven experience with process characterization, scale‑up and tech transfer.
• Proficiency in DoE/statistical tools and technical report writing.
• Available to start on short notice due to contract nature.

Responsibilities

• Lead process development, characterization, and optimization for assigned product/process area.
• Design, execute, and analyze DoE studies and other development experiments.
• Support tech transfer to Galway facility, ensuring robust, scalable processes.
• Author/review process development documentation, risk assessments, and validation docs.
• Identify/troubleshoot deviations, perform root cause analysis, drive CAPAs.
• Collaborate with Manufacturing, Quality, Validation, Regulatory, and Automation teams.
• Support regulatory submissions/inspections with technical data.
• Drive continuous improvement to enhance robustness, yield, and efficiency.
• Provide mentorship to junior engineers.
• Ensure compliance with EU GMP, HPRA, and site EHS.

Skills

DoE methodologies

Statistical tools

Cross-functional collaboration

Technical problem-solving

Education

B.Sc./M.Sc. in Chemical/Biochemical/Process Engineering

Tools

JMP

Minitab

Job description

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.