Process Engineer

Panda International

Leiden

On-site

EUR 60,000 - 86,000

Full time

48 hours ago
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Job summary

Panda International is seeking a process engineer to maintain, improve, and optimize production processes in a GMP-regulated manufacturing environment.

The role focuses on ensuring process reliability, product quality, operational efficiency, and regulatory compliance, while supporting introduction of new processes, monitoring performance, and maintaining critical documentation. You will work with cross-functional teams to drive continuous improvement and sustainable manufacturing performance.

Qualifications

  • 3+ years of experience in process engineering or a similar production role.
  • Experience in GMP-regulated pharmaceutical/biotech manufacturing.
  • Knowledge of GMP requirements and compliant procedures.
  • Experience with process monitoring, troubleshooting and continuous improvement.
  • Experience with process documentation (SOPs, work instructions, batch records).
  • Knowledge of non-conformance investigations, CAPAs and change control.
  • Experience with root cause analysis and implementing corrective actions.
  • Cross-functional collaboration skills.

Responsibilities

  • Maintain, improve, and optimize production processes within a GMP-regulated environment.
  • Support the introduction of new production processes and systems.
  • Monitor existing processes to minimize downtime and production losses.
  • Review and maintain process documentation (SOPs, work instructions, batch records).
  • Conduct quality risk assessments and product impact assessments.
  • Support non-conformance investigations, CAPAs, and change controls.
  • Oversee process and equipment qualification activities.
  • Collaborate with cross-functional teams to drive continuous improvement and sustainable manufacturing performance.

Skills

Analytical and problem-solving
Communication and collaboration
Fluent English (B2+)

Education

HBO degree with at least 3 years of relevant experience

Job description

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 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)
Desirable Skills, Qualifications, and Experience
  • 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
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