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Contract process engineer

Waterford
FPK Engineering Solutions
Contract process engineer
Posted: 4 December
Offer description

Process Engineer (Contract)A client of ours in Waterford city requires a contract Process Engineer to support day-to-day operations across assigned manufacturing areas—such as syringe filling, syringe inspection, or packaging—by optimizing processes, improving equipment performance, and ensuring compliance with GMP and regulatory standards. The role involves driving continuous improvement, supporting key engineering projects, and maintaining high levels of reliability and quality within a fast-paced pharmaceutical environment.Key ResponsibilitiesEngineering Operations & Process OptimisationSupport daily operations by optimizing manufacturing processes and equipment performance.Lead troubleshooting efforts and drive sustainable solutions to ensure operational reliability.Develop and implement production and process controls to meet quality and performance standards.Compliance, CAPA & DocumentationPrepare CAPAs and deviations for assigned manufacturing areas (e.g., syringe filling, inspection, packaging).Lead and participate in investigations, risk assessments, product impact assessments, gap analyses, and generate, review, and execute GMP-compliant documentation and prepare associated technical reports.Ensure all engineering activities adhere to GMP, safety, and regulatory requirements.Equipment & Facility ManagementManage small equipment upgrade projects from concept through to qualification and handover.Coordinate with vendors to resolve equipment issues and implement improvements.Support ongoing maintenance and reliability of equipment.Develop and implement preventative and reactive maintenance strategies aligned with best practices.Perform equipment risk assessments (FMEA) and define appropriate preventative maintenance schedules.Continuous Improvement & SafetyDrive a strong culture of safety, health, and continuous improvement within operations.Identify and implement opportunities to improve efficiency, reliability, and productivity.Qualifications & ExperienceBachelor's degree in Mechanical, Process, Chemical Engineering, or related discipline.Proven experience within the pharmaceutical, biotech, or other highly regulated manufacturing industries.Strong understanding of GMP, deviations, CAPA management, and process optimization principles.Hands-on experience with one of the following; fill-finish operations, syringe filling, automated inspection, or high-speed packaging lines is highly desirable.Excellent problem-solving, communication, and vendor-management skills.Demonstrated ability to built relationships with Engineering, QA and Ops personnel

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