Job Description:

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.

Position Summary:

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

A multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure at the J&J Innovative Medicine site Schaffhausen.

• 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

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An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.