Join an international pharmaceutical company dedicated to improving patient health through innovative therapies. As a Process Engineer, you will lead a project to automate the cleaning of pharmaceutical components. Collaborate with Quality Assurance and engineering teams to ensure compliance with GMP standards. Drive continuous improvement using Lean Six Sigma. This role empowers you to make a significant impact on modernizing manufacturing processes. Find out how this role can provide the challenges you seek.

Over het bedrijf

SIRE Life Sciences

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About the company
This international pharmaceutical company, located in the Oss region, is committed to delivering innovative therapies that improve patient health. With a strong focus on quality and operational excellence, the organization continuously invests in modernizing its manufacturing processes. Employees are empowered to make a real impact by driving continuous improvement and supporting critical production systems.

Role description
As a Process Engineer, you will lead a project to transition the current manual cleaning method for pharmaceutical components to an automated washing system. This role requires deep expertise in change control, equipment qualification, and cleaning validation. You’ll work cross-functionally with Quality Assurance and engineering stakeholders to ensure all deliverables meet GMP standards and regulatory requirements.

Key responsibilities
•   Lead the transition from manual to automated cleaning for pharmaceutical parts
•   Draft and execute change controls, protocols, and reports — all requiring QA approval
•   Manage and support equipment qualification and cleaning validation activities
•   Steer and participate in cross-functional investigations related to deviations and CAPAs
•   Identify and implement process improvements using Lean Six Sigma methodologies
•   Drive continuous improvement initiatives through data-driven decision-making
•   Facilitate kaizen events and coach internal stakeholders on best practices

Requirements

5+ years of experience in a pharmaceutical GMP environment
Deep expertise in change control, equipment qualification, and cleaning validation
Strong verbal and written communication skills in Dutch (mandatory)
Demonstrated ability to manage cross-functional projects and lead investigations
Proficiency with GMP documentation and QA-compliant reporting
Familiarity with Lean Six Sigma, Kaizen, and Change Management is a strong advantage
Enthusiasm for project management and collaboration with multidisciplinary teams

Other information
Apply via the link below!

55073

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