Senior Specialist Data Integrity / CSV

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, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

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