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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