Delivering the best contractor/interim talent in the Life Sciences space.
About the Client
A leading engineering and project delivery consultancy specialising in the Life Sciences sector across Ireland and Europe. Their mission is to design and deliver world‑class pharmaceutical and biotech facilities for pharmaceutical manufacturers.
About the Role
We're seeking an experienced Senior Process Engineer to join a leading pharmaceutical manufacturing facility in Dublin. This is a critical role supporting the production of sterile injectable products in a state‑of‑the‑art GMP environment. You'll be responsible for driving process optimisation, supporting technology transfers, and ensuring manufacturing excellence across multiple production lines.
Key Responsibilities
Process Optimization & Troubleshooting
Lead continuous improvement initiatives to enhance process efficiency, yield, and product quality across aseptic manufacturing operations
Provide technical expertise in troubleshooting complex manufacturing deviations and implementing corrective/preventative actions
Conduct root cause analysis investigations and author technical reports for regulatory submissions
Manage and execute process validation activities including IQ/OQ/PQ protocols for new equipment and processes
Support technology transfers from development sites, ensuring successful scale‑up and commercial launch
Collaborate with cross‑functional teams including Quality, Regulatory Affairs, and Supply Chain on project delivery
Technical Leadership & Compliance
Author and review critical GMP documentation including batch records, SOPs, change controls, and validation protocols
Ensure all activities comply with FDA, EMA, and other regulatory requirements
Mentor junior engineers and provide technical training to operations teams
Support regulatory inspections and client audits as technical subject‑matter expert
Your Profile
Education & Experience
Bachelor's degree in Chemical Engineering, Process Engineering, or related discipline (Master's preferred)
Minimum 5‑7 years' experience in pharmaceutical manufacturing, preferably in sterile/aseptic processing
Proven track record in process optimisation, validation, and technology transfer projects
Technical Skills
Strong understanding of aseptic processing, lyophilization, formulation, and filling operations
Expertise in process validation (Stage 1, 2, 3) and continuous process verification
Proficiency with statistical analysis tools (Minitab, JMP) and process modelling
Working knowledge of engineering principles including P&IDs, mass/energy balances, and equipment design
Regulatory & Compliance
Deep knowledge of ICH guidelines, EU GMP Annex 1, FDA 21 CFR Part 211
Experience supporting regulatory inspections and responding to health authority queries
Strong understanding of risk management tools (FMEA, HACCP)
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Project Management and Manufacturing
Industries
Pharmaceutical Manufacturing and Engineering Services
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