MSAT Senior Engineer Validation

Senior Validation Engineer In MSAT Biotherapeutics

Cilag AG, part of Johnson & Johnson Innovative Medicine, is hiring a Senior Validation Engineer in MSAT Biotherapeutics to enhance our team in Schaffhausen, Switzerland. Johnson & Johnson Innovative Medicine Schaffhausen Site/Cilag AG is a launch site for new products with focus on parenteral products (e.g., pre-filled syringes and vials). We belong to the Manufacturing Science & Technology (MSAT) organization for the MTO (Manufacturing and Technical Operations) Biotherapeutics and Synthetics Manufacturing Platform. We support the parenteral filling, visual inspection, device assembly and pack operations at J&J Innovative Medicine Schaffhausen.

You will be the Site MSAT representative on multi-functional teams leading process validations of automated visual inspection of pre-filled syringes, vials and cartridges as well as device assembly and packaging processes of pharmaceutical products at the Schaffhausen Fill Finish site. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide. You will provide the following:

• Technical support and leadership to top line growth
• Ensure reliability, compliance & efficiency of product value chains end to end
• Integrate manufacturing operations and pharmaceutical development in partnership with product and customer management

Responsibilities:

• Site MSAT lead SME for Device Assembly, Packaging and (Automated) Visual Inspection.
• Accountable to meet project timelines during qualification and validation of visual inspection, device assembly and packaging lines and related processes.
• Own validation activities with internal partners and lead multi-functional project teams.
• Deliver on strategic project goals, process improvements and innovation to ensure competitiveness at the pharmaceutical market and with global players.
• Provide Technical Assessments to Change Controls/CAPAs and Deviations.
• Active participation in audits/health authority inspections as lead (PG26/30) Subject Matter Expert.
• Maintain excellent partnership with all business partners.
• Perform statistical analyses on production data.

Qualifications:

• You have successfully completed your university studies in Engineering, Chemistry, Pharmacy or equivalent and have already gained experience (5+ years) in the pharmaceutical sector with past proven field experience in process validation (ideally in visual inspection, device assembly and packaging).
• You have proven experience in project execution, preferably in the live science and GMP environment. In addition to that you prefer an independent, self-initiative and goal-oriented way of working to apply your expertise and foster collaboration to reach fast paced goals according to management expectations and project schedules.
• Your strength is decision making and problem-solving, paired with exemplary communication skills, enabling you to effectively represent MSAT in cross-fuctional, multi-site teams within a global matrix organization.
• You are open to new ideas, and you drive innovation.
• You are fluent in English and German, with the ability to communicate complex concepts clearly and persuasively across diverse stakeholder groups.

Why join Johnson & Johnson?

• Many opportunities to work on exciting projects and assignments in a dynamic work environment
• A broad spectrum of training opportunities to grow further for personal as well as professional development
• The Johnson & Johnson Pension Fund Switzerland offers attractive performance
• A range of benefits for insurance, childcare, products, sport, culture and much more

Working at Johnson & Johnson is more than a job. We are changing the trajectory of Human Health and working with Johnson & Johnson can change everything. Including you.