Senior Process Validation Engineer - Cleaning Validation
Senior Process Validation Engineer - Cleaning Validation
Location: Switzerland (Hybrid)
Contract: 6 Month Project
Industry: Medical Devices
We are supporting an innovative medical device manufacturer that is seeking a Senior Process Validation Engineer to lead a critical cleaning validation project focused on implantable products.
The primary objective of this role is to develop, execute, and document the validation of the final cleaning process for implant components manufactured through an external supplier network. The successful candidate will play a key role in defining cleaning requirements, establishing scientifically justified cleanliness criteria, and demonstrating that the cleaning process consistently produces products that meet quality and regulatory expectations.
Key Responsibilities:
- Lead the validation of the final cleaning process for implantable medical device components.
- Develop and execute a risk-based cleaning validation strategy.
- Define cleaning requirements, process parameters, acceptance criteria, and validation approach.
- Establish and justify cleanliness requirements based on product risk and manufacturing processes.
- Assess potential contamination sources resulting from machining, manufacturing, handling, and processing activities.
- Perform worst-case assessments of products, materials, geometries, and processing conditions.
- Review and contribute to the development of cleaning validation procedures and related documentation.
- Develop validation plans, protocols, reports, and supporting technical documentation.
- Collaborate with internal stakeholders and external suppliers to ensure successful execution of validation activities.
- Evaluate cleaning equipment, cleaning agents, process controls, and maintenance practices.
- Support supplier assessment activities and ensure alignment with quality and regulatory requirements.
- Drive validation activities through execution, review, approval, and project closure.
Required Experience:
- Degree in Engineering, Life Sciences, Quality, or a related technical field.
- Significant experience in medical device manufacturing or another highly regulated industry.
- Proven experience leading or owning cleaning validation activities.
- Strong understanding of process validation principles and risk-based validation approaches.
- Experience authoring validation protocols, reports, and technical documentation.
- Experience working with external manufacturing suppliers or contract manufacturers.
- Fluent in English & German
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