Senior Operations Process Specialist

Johnson & Johnson seeks a Senior Operations Process Specialist in Schaffhausen to ensure compliant, scalable clinical manufacturing and support facility start-up activities.

This position serves the CM&T Operations organization and the Facility Start-Up Manager. The primary purpose is to enable compliant, scalable clinical manufacturing operations by resolving technical issues, managing quality investigations, and supporting the transition from development to full-scale production.

Responsibilities

• Direct investigations into non-conformities, manage corrective and preventive actions (CAPAs), and confirm their closure in partnership with Quality Assurance.
• Deliver technical expertise and hands-on support for commissioning, qualification, and GMP-compliant daily operations.
• Participate in technical assessments, pilot testing, and process validation while contributing to the creation of standard operating procedures (SOPs) to ensure operational readiness.
• Work with Quality, Engineering, Project Management, and other local teams to address start-up challenges, resolve ramp-up issues, and reduce operational risks.
• Assist in the creation and continuous improvement of GMP documentation.
• Facilitate the technical implementation of New Product Introductions (NPI) in the F2P2 phase and oversee successful aseptic process simulations (APS) before handing over to the operational team.

Requirements

• A completed vocational training in the pharmaceutical sector or a BSc degree in Pharmaceutical, Biochemical, Chemical, or a related scientific discipline.
• Between 5 and 7 years of professional experience in relevant pharmaceutical industry activities.
• Deep technical understanding of aseptic manufacturing technologies and associated processes.
• Mandatory prior experience working in a GMP-regulated production environment.
• Strong command of Annex 1 requirements and contamination control principles specific to aseptic manufacturing.
• Fluency in both German and English, at a very good level for spoken and written communication.

Nice to have

• Background in supporting facility start-up, operational readiness, technology transfer, and qualification activities.

What the company offers

• A multifaceted challenge within a dynamic, international environment featuring high technology standards, attractive terms, and excellent infrastructure.

About the company

Johnson & Johnson operates under the guidance of its Credo, maintaining responsibility to its global workforce. The company fosters an inclusive environment that values each individual, respects employee diversity and dignity, and recognizes merit.

• Guided by the Johnson & Johnson Credo.
• Commitment to an inclusive work environment where every person is valued as an individual.
• Respect for diversity and dignity, with recognition of employee merit.

How to apply

Documents to submit:

• application letter
• testimonials