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
Senior Specialist Data Integrity / CSV (m/w/d, 80-100%), Req:2306152672W, Location: Schaffhausen
in Schaffhausen (Switzerland) to commence immediately or by agreement.
As a specialist in laboratory equipment and software qualification, you will be joining a team which is passionate about introducing new laboratory equipment, laboratory automation and improved software solutions. 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 newly founded Data Governance & Lab Automation team it will be your task to qualify laboratory equipment and software solutions. In addition, you will be responsible for the investigation of instrument and software related deviations and to define and implement corresponding corrective and preventive actions.
If you are also enthusiastic to ensure patient safety by implementing new laboratory equipment, improve lab automation and develop new strategies to ensure data integrity, we would like to meet you.
- 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)
- Authoring and review of procedures (WIs, SOPs) related to equipment lifecycle management
- Installation, configuration, testing and maintenance of application software and system management tools
- Definition of requirements for new software applications, analysis of process and data flows and creation of corresponding flowcharts
- Definition and maintenance of security, backup, and recovery strategies for databases and other data systems
- Migration of data from legacy systems to new solutions
- Provision of operational support for the QC and R&D laboratories
- Troubleshooting to diagnose and resolve software related problems, investigate deviations caused by non-conforming software and implement solutions (CAPA)
- Liaise with vendors and other IT personnel 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. 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:
- PhD / MSc degree in Natural Sciences, Computer Science, Engineering, or alternatively BSc or comparable training with several years of professional experience
Experience and Skills:
- Proven work experience in a GMP-regulated environment, preferably in the field of quality control
- Experience in writing clear, concise and comprehensive qualification documents
- Excellent communication skills
- Experience in project management
- Fluent in English and basic communication in German
- Hands on experience with instrument or software qualification and documentation (e.g., CSV, qualification of production plants, laboratory equipment)
- Experience with databases, networks (LAN, WAN) and patch management
- Excellent analytical skills and problem-solving attitude
- Ability to explain technical details for an audience of non-specialists
- Experience with virtualization (e.g., VMware, Virtual Box)
- Experience with TrackWise, SAP and TruVault is an advantage