• Job title Manager RD
• Function R&D Product Development
• Sub function R&D Process Engineering
• Category Manager, R&D Process Engineering (PL7)
• Location Schaffhausen / Switzerland
• Date posted Mar 19 2026
• Requisition number R-064594
• Work pattern Fully Onsite

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

The Schaffhausen Fill & Finish Pilot Plant (F2P2) manufactures parenteral biologics and device assembly products for clinical trials and supports technology transfer to commercial manufacturing. Johnson & Johnson’s Clinical Manufacturing & Technology team is seeking a Facility Start Up Manager based in Schaffhausen, Switzerland.

The Facility Start-Up Manager will ensure operational readiness by managing the start-up of expanded clinical manufacturing zones and overseeing upgrades to existing production areas until they are handed over to routine clinical operations. He/She will technically lead the start-up project team in a matrix organization and ensure that facilities and equipment meet sterile and device assembly production requirements, establish operational flows and ensure compliance with GMP, J&J/site policies and Annex 1. The Facility Start Up Manager will ensure new equipment and processes are aligned with the commercial facility and maintain continuous harmonization between both to enable seamless scale-out and technical transfers. Following handover, the Manager will retain a leadership role in the area.

Main responsibilities include the following:

• Technical lead of a cross-functional team

• Responsible to ensure operational readiness of pilot plant

• Development of an operational flow with hand-over to production team

• Ensure technological alignment and site harmonization or seamless scale‑out and BCP readiness.

• Ensure EHS compliance and employee safety across all project stages - mitigate hazards, coordinate with EHS, and embed safety into operations.

• Support qualification requirements and responsible for validation of new facility, processes and equipment

• Provide design input to engineering projects to ensure technical solutions meet production needs

• Collaborate with extended site stake holders to ensure supporting processes are in place and staffed sufficiently

• Create capacity plan for new facility in support of global production planning

• Define operating model and training approach for production personnel and assure timely implementation

• Define and ensure availability of all new process materials and consumables in coordination with Supply Chain.

• Responsible for establishing all required GMP documentation

• Responsibility for successful aseptic process simulation with hand-over to operational team

For this position we are looking for an experienced professional with working experience in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines), project management, effective communication, leadership and excellent interpersonal skills to build a reliable network within a matrix organization.

The following hard skills are required:

• Master’s degree in engineering or scientific discipline (e.g., Bioprocess, Chemical, Mechanical, Biotechnology, Pharmaceutics).

• At least 5-7 years of professional experience in related activities in the healthcare industry

• Excellent technical understanding of aseptic filling technologies and processes

• Production experience within a GMP regulated environment (pharmaceutical preferred)

• Excellent interpersonal skills

• Change management skills

• People leadership experience

• Project leadership experience

• Excellent analytical skills, communication strength, empathy, assertiveness and high customer and business orientation.

• Very good level of German and English both spoken and written.

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