Senior Process Engineer | API Manufacturing Expansion ProjectCork, IrelandSite-BasedENG 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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