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 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.

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.

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.

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

Qualifications

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. In addition to your assertiveness, you are willing to take on responsibility and enjoy making a difference and advancing projects.

In addition, you have the following qualifications:

Education:

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

Experience and Skills:

Required:

• 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

Preferred:

• 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 TruVault is an advantage

Required Skills: