Within the department
Quality Assurance, part of the Janssen Supply Chain Beerse QA organization we currently are recruiting a
QA Validation Engineer Process-, Cleaning- & Sterilisation Validation for commercial manufacturing. This function is situated in the QA Qualification and Validation department. This department is responsible for qualification and validation of production- and lab equipment, utilities, computer systems, production- and cleaning processes and sterilization processes. The
QA Validation Engineer Process-, Cleaning- & Sterilisation Validation for commercial manufacturing reports into the QA Qualification/Validation Principal Engineer.
Purpose of the position:
- Responsible to maintain the process validation status of pharmaceutical products in the Parenteral and eyedrop production area for commercial manufacturing.
- Responsible to maintain the cleaning validation status of equipment used in these manufacturing areas.
- Responsible to maintain the validation status of sterile processes (parenteral production, aseptic processing) in these manufacturing areas.
- Act as responsible sterility engineer.
- Act as Subject Matter Expert for validation related topics for change control and deviation handling.
- Issue, review and approve validation documents such as validation plans, protocols, reports, master documents, rationales, statements, SOPs, cleaning recipes,... in order to maintain compliance to regulations, guidelines, J&J policies and standards.
- Execute process-, cleaning- and sterilization validation runs.
- Maintain a current knowledge of international regulations, guidelines and new evolutions related to validation topics through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Validation standards at Janssen.
- Prepare for regulatory and customer audits and inspections.
- Be the spokesperson for validation related matters during audits and inspections.
- Be part of tech transfer teams and interact with other groups for the introduction of new products and new systems and processes. Give advice and support for the preparation of validation related activities and guard the cGMP aspects in new projects. Be a member of cross-functional teams to realize cross-departmental objectives.
