Qualification Specialist (m/w/d)

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine Site in Schaffhausen is seeking an experienced Qualification Specialist (m/w/d, 80–100%) to support GMP-compliant lifecycle management of laboratory equipment within QC Lab Services.

You will plan, coordinate, execute, and document qualification activities and collaborate with QA, Engineering, IT, suppliers, and manufacturers to ensure compliant and reliable equipment lifecycle solutions.

Qualifikationen

• Completed vocational training in scientific or technical field in a regulated laboratory or GMP setting.
• Bachelor’s or Master’s degree in life sciences, engineering, chemistry, pharmacy, or related discipline.
• Several years of practical experience in GMP-regulated environment and laboratory equipment qualification.

Aufgaben

• Plan, coordinate, execute, and document qualification activities for laboratory equipment per GMP and internal requirements.
• Prepare lifecycle documentation including risk assessments, user requirements, qualification protocols, reports.
• Support change controls, deviations, CAPAs, maintenance, calibration, and troubleshooting for laboratory equipment.
• Collaborate with QA, Engineering, IT, suppliers, and manufacturers to ensure compliant lifecycle solutions.

Jobbeschreibung

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

Required

Experience and Skills

• Several years of practical experience in a laboratory, technical, quality, production, maintenance, or GMP-regulated environment
• Interest in laboratory equipment, qualification activities, technical processes, and GMP-compliant documentation
• Strong ownership, reliability, and communication skills when working with laboratories, Quality Assurance, Engineering, IT, suppliers, and manufacturers
• Good Microsoft Office skills and business-fluent German with good English skills

Preferred

• Experience in equipment qualification, validation, calibration, laboratory operations, quality systems, change control, deviations, CAPA, or data integrity
• Experience with SAP, QMS tools, document management systems, or laboratory software is an advantage

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s What You Can Expect

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Required Skills

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy