Lab Equipment Qualification Specialist

Lab Equipment Qualification Specialist

Are you great at organizing knowledge and connecting dots? Do you enjoy having things in order and assuring that everything makes perfect logical sense? Are you the kind of person who is ready to find solutions to complex problems and stays level-headed when request pile up? Would you like to use these skills to improve lives of cancer patients at the frontier of medical research? If the answer to these questions is yes, we are looking for you!

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 https://www.jnj.com/.

The Cilag AG is an international manufacturing company of the Johnson & Johnson Group's Janssen pharmaceutical division and manufactures pharmaceutical products and medical devices as well as active pharmaceutical ingredients (APIs) for global markets at its production site in Schaffhausen. With its innovative products, processes, and technologies, Cilag AG is one of the leading pharmaceutical companies in Switzerland and at the same time a strategic location for product launches.

Within the Quality Control (QC) department, we are looking for a dedicated personality as Lab Equipment Qualification Specialist (m/w/d, 80-100%)
in Schaffhausen (Switzerland) to commence immediately or by agreement.

What you will be doing:

As a specialist in laboratory equipment qualification, you will be joining a team which is passionate about introducing new and improving currently deployed laboratory equipment. You will be part of the Lab Services department of Site Quality Control and as such responsible for the lifecycle management of the laboratory equipment.

What impact will you also have:

As part of the Equipment Lifecycle Management team, it will be your task to qualify laboratory equipment. In addition, you will be supporting the investigation of instrument related deviations and the implementation of corresponding corrective and preventive actions. You will be the first point of contact  for all questions concerning the laboratory systems.
If you are also enthusiastic to ensure patient safety by implementing new laboratory equipment and improve lab equipment qualification, we would like to meet you.

In your day-to-day job you will:

• Planning and coordinating qualification activities for laboratory equipment in compliance with current GMP and regulatory requirements


• Preparation and execution of change control records related to equipment lifecycle management


• Creation of detailed, comprehensive, and well-structured qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, IOPQ protocols and decommissioning documents)


• Drafting of procedures (WIs, SOPs) related to equipment lifecycle management


• Identification and documentation of relevant compendial requirements for analytical equipment


• Operational support for the QC and R&D laboratories


• Troubleshooting to diagnose and resolve problems


• Supporting of investigations into deviations caused by non-conforming instruments and implement solutions (CAPA)


• Liaise with vendors for problem resolution (e.g., technical support for manufacturer qualifications, maintenance & calibration, troubleshooting and investigations)