NL - Engineer 3, Process

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.

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 [email protected].

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