Senior Process Engineer | API Manufacturing Expansion Project
Cork, Ireland
Site-Based
ENG Bauen is supporting a leading global pharmaceutical company in delivering a major expansion project, requiring an experienced Process Engineer to oversee critical process evaluations within an API manufacturing environment. This is an opportunity to play a key role in a high-value investment program, ensuring that Commissioning, Qualification, and Validation (CQV) activities align with production requirements.
Our client is making significant investments in state-of-the-art manufacturing technology to enhance production efficiency and maintain world-class pharmaceutical standards. As part of this strategic expansion, they require a Process Engineer to act as a key interface between CQV teams, Quality Assurance, and production operations, ensuring all process changes comply with regulatory and operational standards.
This is an excellent long-term opportunity within a company at the forefront of pharmaceutical manufacturing advancements.
Key Responsibilities:
* Act as the voice of production in evaluating CQV activities, ensuring new systems and modifications meet operational needs.
* Pre-approve qualification documents, verifying compliance before final QA sign-off.
* Assess and verify instrumentation changes, including valves, temperature sensors, and process control systems.
* Update P&IDs to reflect modifications within the production area.
* Ensure that all process changes align with GMP, safety, and regulatory standards.
Required Skills & Experience:
* Degree in Chemical Engineering, Process Engineering, or related discipline.
* Strong experience in API manufacturing and process engineering within the pharmaceutical sector.
* Working knowledge of CQV principles, with experience in assessing qualification work from a production perspective.
* Familiarity with GMP, regulatory compliance, and quality assurance processes.
* Hands-on experience with valves, temperature sensors, and instrumentation systems.
* Ability to interpret and update P&IDs in response to system modifications.
If you are interested in this opportunity, please apply or send your CV via the ENG Bauen website or LinkedIn page.
Keywords:
Process Engineer, API Manufacturing, Pharmaceutical Process Engineer, CQV Process Engineer, GMP Process Engineer, API Compliance Engineer, Process Control Engineer, Commissioning & Qualification Engineer, P&ID Engineer, Process Validation Engineer, Chemical Process Engineer, API Site Engineer.
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