Specialist - Data Integrity / CSV

Johnson & Johnson; Schaffhausen; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Collaborative culture

Work-life balance

Cross-functional teamwork

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland, is seeking a Specialist - Data Integrity / CSV to oversee laboratory computerized systems through GMP-compliant lifecycle management. You will liaise with Quality Control, IT, and vendors to ensure reliability and compliance.

The role requires strong data integrity principles, experience with CSV, and cross-functional project coordination, with English proficiency and German as a plus. On-site in Schaffhausen.

Qualifikationen

• Ph.D./Master's in a relevant field or equivalent GMP experience.
• Experience with CSV, laboratory IT, or data governance.
• Strong data integrity and risk management knowledge.
• Excellent English; German is a plus.

Aufgaben

• Lead lifecycle activities for GMP-relevant laboratory systems.
• Coordinate software qualification, validation, and lifecycle tasks.
• Develop and maintain SOPs and work instructions.
• Provide IT and analytical software support for GMP labs.
• Manage CAPAs and non-conformances with cross-functional teams.

Kenntnisse

Data integrity

GMP compliance

Quality systems

Project coordination

Technical communication

Ausbildung

Ph.D., Master’s degree or comparable in natural sciences, computer science, engineering

Jobbeschreibung

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

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for a passionate individual to join our Quality Control team us as a Specialist - Data Integrity / CSV (80-100%) in Schaffhausen, Switzerland.

Purpose:

You will take responsibility for laboratory computerized systems and analytical software used in regulated laboratory operations. This covers Windows endpoints, application servers, validated analytical software, user access controls, system documentation, and related lifecycle activities Acting as a key interface between Quality Control, Quality Assurance, IT, vendors, and laboratory users you will ensure that our computerized laboratory systems remain compliant, reliable, future-ready and fit for GMP use throughout their lifecycle.

You will be responsible for:

Laboratory Computerized Systems Lifecycle:

• Ensure timely and cost-effective execution of software qualification, validation, and lifecycle activities for GMP-relevant laboratory computerized systems.
• Coordinate software qualification, validation, administration, and lifecycle activities for laboratory systems in collaboration with business departments, Quality Assurance, global and local IT, vendors, and other relevant stakeholders.
• Create, maintain, and update SOPs and work instructions within the assigned area of responsibility.

Projects, Infrastructure & Technical Support:

• Support and execute cross-functional projects related to laboratory equipment qualification, analytical software implementation, Windows lifecycle activities, system upgrades, and infrastructure changes.
• Provide technical support and troubleshooting for laboratory IT incidents, analytical software issues, Windows-related problems, vendor support activities, and business continuity topics affecting GMP laboratory operations.

Compliance, Controls & Non-Conformances:

• Ensure compliance with applicable GMP, EHS, SOX, and internal procedural requirements associated with the role.
• Support and manage non-conformances, including technical assessment, documentation, impact or risk evaluation, and implementation of preventive and corrective actions (CAPAs).

Qualifications / Requirements:

• Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field; equivalent practical experience in a GMP laboratory, CSV, laboratory IT, or data integrity environment may also be considered.
• Relevant experience in at least one of the following areas: laboratory equipment qualification and software validation within a GMP-regulated environment; or laboratory IT and system administration in a quality-controlled laboratory setting.
• Additional IT experience, such as Windows administration, analytical software administration, user access management, application troubleshooting, or collaboration with IT support organizations or external vendors, is considered an advantage.
• Experience with Quality Risk Management in accordance with ICH Q9, including data and process mapping.
• Strong understanding of data integrity and data governance principles, with the ability to apply them in GMP-relevant laboratory processes and computerized systems.
• Experience contributing to or coordinating cross-functional projects, ideally involving laboratory systems, software implementation, infrastructure changes, or compliance-related improvements.
• Experience in managing non-conformances, preparing impact assessments, and implementing CAPA actions.
• Proficient use of Microsoft Office applications and standard business productivity tools.
• Excellent organizational and communication skills, a goal-oriented working style, and a strong can-do mindset.
• Good command of English, including the ability to read, write, and review technical and GMP-relevant documentation; good command of German will be an added advantage.

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, cross-functional teamwork, and continuous improvement

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy

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