Senior Process Engineer – Pharmaceutical Cleaning Validation Oss • SIRE Life Sciences
Gevraagd
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37 - 40 uur
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Senior
Aanbod
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Vast contract
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The Company
Our client is a global healthcare company specializing in women's health, biosimilars, and established medicines. It focuses on providing innovative solutions in reproductive health, contraception, fertility treatments, and other therapeutic areas. The company aims to improve health outcomes for women and families worldwide through a wide range of products.
The Role
As a Senior Process engineer you will be responsible for transitioning manual cleaning processes to automated systems while ensuring regulatory compliance. The role manages change control, equipment qualification, and cleaning validation to optimize processes. It involves producing QA-approved validation documents and applying Lean Six Sigma to enhance efficiency and resolve issues.
Responsibilities
- Transition manual cleaning processes to automated systems.
- Ensure compliance with regulatory and GMP standards.
- Manage change control for equipment and process modifications.
- Qualify equipment to meet performance and regulatory requirements.
- Validate cleaning methods to prevent contamination.
- Apply Lean Six Sigma for process improvements and issue resolution.
- Produce and submit QA-approved validation documents.
- Collaborate with cross-functional teams for continuous improvement.
- Minimum 5 years of experience as a Process Engineer in the pharmaceutical industry.
- Expertise in cleaning validation, equipment qualification, and change control.
- Strong knowledge of regulatory standards (e.g., GMP) and quality systems.
- Proficient in Lean Six Sigma methodologies for process improvement.
- Excellent verbal and written communication skills in Dutch.
- Ability to produce QA-approved validation documents and collaborate with cross-functional teams.
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