At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 Groups 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 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)

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

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 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:

Preferred Skills: