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Job Title: Senior Specialist Data Integrity / CSV (80-100%)

Location: Schaffhausen, Switzerland | Flexible start date

At Johnson & Johnson, health is at the heart of everything we do. Leveraging our strength in healthcare innovation, we empower a world where diseases are prevented, treated, and even cured. At Cilag AG, part of Johnson & Johnson’s Janssen Pharmaceutical division, we produce pharmaceutical products, medical devices, and active pharmaceutical ingredients (APIs) for global markets.

We are seeking a passionate Senior Specialist, Data Integrity / CSV to champion the lifecycle management of laboratory equipment, enhance data governance practices, and contribute to lab automation. Join our Site Quality Control team in Schaffhausen and make a difference in patients' lives globally.

Key Responsibilities:

Laboratory Equipment & Software Qualification:

• Plan and coordinate qualification activities (in line with GMP and regulatory standards)

• Author comprehensive qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, IOPQ protocols)

• Authoring and review of procedures (WIs, SOPs) related to data integrity and equipment lifecycle management

• Perform installation, configuration, testing, and troubleshooting on laboratory systems

Data Integrity & Governance:

• Define requirements for new software solutions and analyze data/process flows

• Develop and oversee security, backup, and recovery strategies for laboratory systems (e.g., databases)

• Archive or migrate legacy system data

• Investigate data integrity issues and software non-conformities (CAPA)

Cross-functional Collaboration:

• Act as a bridge between internal teams (Quality Control, R& D, IT) to ensure seamless integration of laboratory systems and data workflows.

• Collaborate effectively with external vendors for technical support, including manufacturer qualifications, maintenance, troubleshooting, and investigations.

• Provide training and guidance to end-users, fostering cross-functional understanding of laboratory systems and automation processes.

• Lead initiatives to improve interaction between teams by streamlining communication on project requirements, system upgrades, and troubleshooting efforts.

Qualifications:

Education:

• Ph.D. or M.Sc. in Natural Sciences, Computer Science, Engineering, or related field
  (Alternatively: Bachelor’s degree with several years of relevant experience in a GMP setting)

Required Skills & Experience:

• Proven work experience in GMP-regulated environments (preferably Quality Control)

• Strong analytical and problem-solving skills

• Experience drafting qualification documents (clear, concise, accurate)

• Fluent in English and basic spoken German skills (B1 or above desirable)

Preferred Skills & Technologies (advantageous but not required):

• Hands-on familiarity with laboratory equipment qualification, CSV, databases, or virtualization (e.g., VMware)

• Experience with SAP, TrackWise, or TruVault

• Ability to convey technical material to non-specialists

What We Offer:

• Opportunities to shape laboratory innovation in a global company at the forefront of healthcare

• Accessible location in beautiful Schaffhausen

• Collaborative, inclusive work environment that values work-life balance