Process Engineer (Project User Representative) - API

Cork
Contract
Full-time

1 month ago

We are seeking a Process Engineer to act as a User Representative for a leading global pharmaceutical manufacturer. This role is pivotal in a low-complexity, high-volume capital project within the API (Active Pharmaceutical Ingredient) space.You will be the bridge between the Project Engineering team and the Site Operations team, ensuring that all equipment and processes meet the highest standards of safety, usability, and GMP compliance before handover.Key Responsibilities

Documentation Lifecycle: Manage a high volume of protocol reviews and approvals (IQ/OQ/PQ) ensuring strict adherence to site standards.
Technical Review: Lead P&ID reviews and "walk-downs" to verify that the physical installation matches the design intent.
Mechanical Completion: Oversee the compilation and review of MC Packs, ensuring all mechanical and piping milestones are verified.
Stakeholder Liaison: Act as the primary technical point of contact for the "End User" (Operations), ensuring the equipment is fit-for-purpose.
Troubleshooting: Identify and resolve technical bottlenecks during the commissioning and qualification phases.

Requirements

Experience: 3-7+ years in a Process Engineering or CQV role within a GMP environment.
Sector Expertise: Strong background in API (Small or Large Molecule) manufacturing is essential.
Technical Skills: Proficient in reading P&IDs and managing complex documentation suites (validation protocols).
Mindset: Highly organized with an "eye for detail"-this role involves significant document-heavy verification work.
Education: Degree in Chemical Engineering, Mechanical Engineering, or a related discipline.

Morgan McKinley

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