Process Engineer

Process Engineer Responsible for maintaining, improving, and optimizing production processes within a GMP-regulated manufacturing environment. The role focuses on ensuring process reliability, product quality, operational efficiency, and compliance with applicable regulations. Responsibilities include supporting the introduction of new production processes and systems, monitoring existing processes to minimize downtime and production losses, reviewing and maintaining process documentation such as SOPs, work instructions, and batch records, conducting quality risk assessments and product impact assessments, supporting non-conformance investigations, CAPAs, and change controls, overseeing process and equipment performance qualification activities, and collaborating with cross-functional teams to drive continuous improvement and sustainable manufacturing performance. Non-Negotiable Skills, Qualifications, and Experience Relevant HBO degree with at least 3 years of relevant experienceExperience in process engineering or a similar role within a production environmentExperience working in a GMP-regulated pharmaceutical, biotechnology, or other relevant manufacturing environmentKnowledge of GMP requirements and compliance with manufacturing proceduresExperience with production process monitoring, troubleshooting, and continuous improvementExperience with process documentation, including SOPs, work instructions, and batch recordsKnowledge of non-conformance investigations, CAPAs, and change controlStrong analytical and problem-solving skills, including identifying root causes and implementing solutionsStrong communication and collaboration skills, with the ability to work with cross-functional teamsFluent English (B2 level or higher) Desirable Skills, Qualifications, and Experience Experience with process qualification, performance qualification (PQ), or validation activitiesExperience conducting quality risk assessments and product impact assessmentsKnowledge of root cause analysis and deviation managementExperience conducting Gemba walks and identifying improvements on the production floorExperience with Lean, Six Sigma, or other continuous improvement methodologiesKnowledge of process performance monitoring, yield optimization, and downtime reductionExperience supporting audits and regulatory inspectionsStrong stakeholder management and documentation skillsAbility to manage multiple priorities and work effectively in a changing production environment Practicalities Start Date: ASAP Contract Duration: 12 months Location: Leiden Netherlands Interested in discussing this opportunity or know someone who could be a great fit? Send your CV to e.cabral@panda-int.com.