Lab Equipment Qualification Specialist

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 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 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.

As a specialist in laboratory equipment qualification, you will be joining a passionate team that introduces new and improves currently deployed laboratory equipment. You will be part of the Lab Services department of Site Quality Control and be responsible for the lifecycle management of laboratory equipment.

As part of the Equipment Lifecycle Management team, your tasks include qualifying laboratory equipment, supporting investigations of instrument related deviations, implementing corrective and preventive actions, and serving as the first point of contact for all questions concerning laboratory systems.

Key Responsibilities:

• 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 investigations into deviations caused by non-conforming instruments and implementing solutions (CAPA)

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

You enjoy working in a team and have strong teamwork and communication skills. You approach challenges in a solution-oriented and systematic manner, can solve complex and multi-layered tasks and set the right priorities. You are assertive, willing to take on responsibility, and enjoy making a difference and advancing projects.

Relevant educational background in a regulated environment.

• Experience with various analytical techniques, preferably in a regulated environment
• Excellent communication skills
• Experience in project management
• Very good knowledge of Microsoft Office programs (Outlook, Word, Excel, PowerPoint)
• Fluent in English and German

• Experience working with pharmacopeia
• Hands-on experience with instrument qualification and documentation (e.g., qualification of production plants, laboratory equipment)
• Excellent analytical skills and problem-solving attitude
• Experience with QMS, SAP and Tru Vault is an advantage