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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Schaffhausen, Switzerland
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, 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit
Senior Qualification Specialist – QC Lab Services (Data Integrity / CSV) | 80–100% Location: Schaffhausen, Switzerland | Flexible start date
About the role:
At Johnson & Johnson Innovative Medicine, we put health at the heart of everything we do. At our Schaffhausen site, we produce pharmaceutical products, medical devices, and active pharmaceutical ingredients (APIs) for global markets.
Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories. You will drive lifecycle management of analytical instruments (e.g., HPLC, GC, UV/VIS) and non‑analytical utilities (e.g., fridges, freezers, centrifuges, autoclaves, LAFs), ensuring data integrity and regulatory compliance across systems with and without software in scope.
What you’ll do:
Instrument Qualification
- Plan, coordinate, and execute equipment qualification and re‑qualification (IQ/OQ/PQ) in line with GMP and site standards
- Author and review lifecycle documentation (e.g., URS, risk assessments, traceability, protocols, test scripts, reports)
- Oversee vendor/manufacturer qualifications and integrate supplier documentation into site deliverables
- Perform/coordinate installation, configuration, and testing
- Drive troubleshooting and remediation
Computer System Validation & Data Integrity
- Execute CSV for analytical software and computerized systems per GAMP 5, 21 CFR Part 11, and EU GMP Annex 11
- Define and verify requirements, functional designs, and data/process flows
- Establish and assess controls for user management, audit trails, e‑signatures, backup/restore, disaster recovery, and corresponding periodic review
- Manage data migration/archiving for legacy systems
Procedures, Governance & Continuous Improvement
- Author and revise WIs/SOPs related to equipment lifecycle, CSV, and data integrity
- Plan and steer (re‑)qualification campaigns involving multiple departments (QC, QA, IT, Engineering)
- Drive standardization and simplification across labs
- Investigate and close DI/CSV deviations with effective CAPAs
Leadership, Training & Stakeholder Management
- Guide and supervise cross‑functional project teams and coordinate timelines and resources
- Train and mentor colleagues on CSV, Annex 11/Part 11, data integrity, and qualification best practices
- Collaborate with internal partners and external vendors
- Support internal/external audits and health authority inspections
What you’ll bring:
Education
- MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
- Alternatively, a Bachelor’s degree with substantial, relevant GMP experience
Required experience & skills
- Proven experience qualifying laboratory equipment in a GMP environment—both with and without software applications in scope
- Hands‑on CSV experience for laboratory/software systems in line with GAMP 5, 21 CFR Part 11, and EU GMP Annex 11
- Strong documentation skills across the validation lifecycle (URS, risk assessments, IQ/OQ/PQ, testing, traceability, reports)
- Practical understanding of data integrity controls (e.g., audit trail review, backup/restore testing)
- Excellent cross‑functional coordination, project planning, and problem‑solving skills
- Fluent English; German at B1 or higher desirable
Nice to have
- Experience with QC quality systems and tools (e.g., TrackWise for deviations/CAPA, SAP, electronic document management such as TruVault)
- Familiarity with databases, virtualization (e.g., VMware), networked lab systems, and Windows domain environments
- Exposure to lab automation and integration across multiple analytical platforms
What we offer
- A high‑impact role shaping laboratory reliability, compliance, and automation within a global healthcare leader
- An inclusive, collaborative environment with strong support for work‑life balance
- A well‑connected location in Schaffhausen and opportunities for ongoing development
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy