NL - Engineer 3, Process

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.

• Relevant HBO degree with at least 3 years of relevant experience

• Experience in process engineering or a similar role within a production environment

• Experience working in a GMP-regulated pharmaceutical, biotechnology, or other relevant manufacturing environment

• Knowledge of GMP requirements and compliance with manufacturing procedures

• Experience with production process monitoring, troubleshooting, and continuous improvement

• Experience with process documentation, including SOPs, work instructions, and batch records

• Knowledge of non-conformance investigations, CAPAs, and change control

• Strong analytical and problem-solving skills, including identifying root causes and implementing solutions

• Strong communication and collaboration skills, with the ability to work with cross-functional teams

• Fluent English (B2 level or higher)

• Experience with process qualification, performance qualification (PQ), or validation activities

• Experience conducting quality risk assessments and product impact assessments

• Knowledge of root cause analysis and deviation management

• Experience conducting Gemba walks and identifying improvements on the production floor

• Experience with Lean, Six Sigma, or other continuous improvement methodologies

• Knowledge of process performance monitoring, yield optimization, and downtime reduction

• Experience supporting audits and regulatory inspections

• Strong stakeholder management and documentation skills

• Ability to manage multiple priorities and work effectively in a changing production environment

Start Date: ASAP Contract Duration: 12 months Location: Leiden, Netherlands

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