Process Validation Engineer

Ref jobup.ch: 2352481 | Date: 10 Juin 2024

The Design transfer and Process validation engineer will ensure that the manufacturing processes of product are well designed, validated, optimized and compliant, ultimately contributing to the production of high quality products that meet regulatory requirements and customer expectations.

Process Validation Engineer

Swiss company involved in the development of advanced medical products.

Description

Transfer of the design of new products

• Work closely with the various departments and contract manufacturing organization to ensure the transfer of design into production of new products.
• Major stakeholder in the implementation of documentation to ensure the transfer stages from design to production of new products.
• Participate in the training of production teams to ensure the transfer of design into production of new products.

Qualification and validation of equipment and processes.

• Define and implement process validation plans in accordance with
• Coordinate, supervise and/or plan process validation, equipment qualification, sterilization, cleaning validation and computerized systems activities in accordance with
• Control the implementation of all qualification and validation activities to guarantee the maintenance of validated statuses (equipment, processes, etc.).
• Contribute to the validation protocols and
• Participate to the continuous assessment and optimization of manufacturing processes to improve efficiency, reduce costs, and enhance product quality.
• Participate in the identification and assessment of risks associated with manufacturing processes and take part in the development of strategies to mitigate these risks to ensure product consistent with defined final specifications.
• Represent the validation department during inspections and/or audits by regulatory agencies when required and provide necessary documentation.

Technology operations

• Technology Transfer: together with the MS&T Manager, collaborate with R&D and QA/RA to facilitate the successful transfer of new products and technologies from the R&D phase to manufacturing. This includes providing expertise on scalability, process capability, and troubleshooting potential issues during the transfer.
• Major stakeholder in the resolution of non conformity related to products.
• Take part in supplier audits.
• Validation expert as single point of contact with the contract manufacturing organization.

Profile

EDUCATION/LANGUAGES

• Degree in the field of medical technology, engineering or related field
• Fluency in English.

PROFESSIONAL SKILLS & EXPERIENCE

• First experience in industrialization and validation within Medical device industry
• Good understanding of the different value streams
• Good understanding of highly regulated environments
• Strong knowledge of ISO 17665-1 for the final sterilization of the product as well as ISO 13485 (quality management system for Medical Device) and ISO 14971 (risk management for Medical Device)
• Excellent computer skills

PERSONAL SKILLS & COMPETENCIES

• Strong ethics, creativity and problem solving abilities
• Proactive and ability to initiate and self-start projects
• Positive, flexible and resilient. Ability to handle ambiguity & changes
• Excellent planning, communication and presentation skills
• Strong team player and ability to work across functions

Job Offer

Long-term project with possibility of internalisation