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Job Description:

Join us in creating a future where diseases are no longer a concern! Johnson & Johnson Innovative Medicine in Schaffhausen (Cilag AG) specializes in the production of pharmaceuticals and active ingredients. The Schaffhausen site plays a strategic role in launching and growing some of Johnson & Johnson' s key pharmaceutical products. Utilizing advanced technologies and processes, this site manufactures a variety of pharmaceutical dosage forms and chemical active ingredients. We are currently looking for a Senior/Staff Cleaning Validation Engineer in MSAT (Manufacturing, Science & Technology) Biotherapeutics to enhance our team.

POSITION SUMMARY:

As an MSAT Senior/Staff Validation Engineer, you will be responsible, alongside other team members, for developing, maintaining, and preparing reliable cleaning processes for product- and indirect-product contact parts to meet future requirements. This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

KEY RESPONSIBILITIES:

• Develop and validate cleaning processes for new products.
• Develop and validate improved cleaning processes for existing products.
• Develop and implement new strategies for cleaning validation.
• Propose and support technical improvements to cleaning systems (CIP/COP).
• Create documents for cleaning validation activities (protocols, reports, risk assessments, SOPs).
• Coordinate cleaning validation activities with other departments.
• Calculate permissible limits for cleaning validation.
• Lead and participate in investigations and change controls.
• Prepare technical assessments for investigations and change controls.
• Represent MSAT in cross-departmental projects and global meetings.
• Maintain an excellent partnership with all business partners at the site and within J& J.
• Present cleaning validation during audits/inspections.
• Contribute to the digital transformation of MSAT (e.g., digitization and automation of reports, data management, visualization, evaluation of new technologies).
  

Qualifications:

As an ideal candidate, you have:

• A Bachelor’s or Master’s degree in Life Sciences or Engineering.
• At least 5 years of experience in the pharmaceutical industry.
• A minimum of 2 years of experience in cleaning validation (operations, engineering, quality department, etc.).
• Led investigations and change control projects.
• Experience in project management.

You are:

• Proficient in German and English, both in communication and negotiation.
• Customer-oriented and quality-conscious.
• Strong in decision-making and problem-solving.
• An innovative team player who can propose creative and pragmatic solutions.
• Able to work in a complex global matrix organization with multiple stakeholders.
• Interested in digital transformation and capable of proposing and implementing corresponding process improvements.

We offer:

• A versatile challenge in a dynamic, international environment with attractive conditions and career opportunities, as well as good infrastructure at the Schaffhausen site.
• Many opportunities to work on exciting projects and assignments.
• Support for childcare.
• A wide range of training opportunities for personal and professional development.
• Attractive benefits from the Johnson & Johnson pension scheme in Switzerland.
• A variety of perks for insurance, products, sports, culture, and much more.