Qualification Specialist (m/w/d)
Johnson & Johnson
- Location
- Schaffhausen, Switzerland
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 2 approvals (FY2023)
- Posted
- 14h ago
About this role
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. Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Schaffhausen, Switzerland Job 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, treatments are smarter and less invasive, and solutions are personal. The Johnson & Johnson Innovative Medicine Site in Schaffhausen is an international manufacturing company for pharmaceutical products, medical devices, and active pharmaceutical ingredients (APIs) for global markets. With its innovative products, processes, and technologies, the Johnson & Johnson Innovative Medicine Site in Schaffhausen is one of the leading pharmaceutical companies in Switzerland and a strategic site for product launches and long-term growth. Within the Equipment Lifecycle Management (ELM) team in the Quality Control (QC) department, we are looking for an experienced, reliable, and committed professional as Qualification Specialist (m/w/d, 80–100%) in Schaffhausen, Switzerland, to commence immediately or by agreement. This role is designed for a long-term professional who brings practical experience, sound technical understanding, and a strong quality mindset to a highly regulated pharmaceutical environment. We particularly welcome candidates with completed vocational training in a scientific or technical field and relevant experience. A degree in life sciences, engineering, or related discipline is also welcome. As a Qualification Specialist, you will support the GMP-compliant lifecycle management of laboratory equipment within QC Lab Services. You will plan, coordinate, execute, and document qualification activities and work closely with QC laboratories, Quality Assurance, Engineering, IT, suppliers, and manufacturers.
Key Responsibilities
Plan, coordinate, execute, and document qualification and requalification activities for laboratory equipment in line with GMP, regulatory, and internal requirements Prepare and maintain lifecycle documentation, including risk assessments, user requirements, qualification protocols, reports, periodic reviews, and decommissioning documents Support change controls, deviations, CAPAs, maintenance, calibration, and troubleshooting activities related to laboratory equipment Collaborate with internal stakeholders, suppliers, and manufacturers to ensure compliant and sustainable equipment lifecycle solutions Qualifications You are a reliable, team-oriented professional with strong communication skills, a structured working style, and the ability to take ownership in a regulated environment. You act with a high level of quality awareness, set clear priorities, and enjoy working across functions.
Education
Completed vocational training in a scientific or technical field, preferably with professional experience in a regulated laboratory, pharmaceutical, technical, or GMP environment Alternatively, a bachelor’s or master’s degree in life sciences, engineering, biotechnology, chemistry, pharmacy, or a related discipline Experience and Skills Required: Several