Specialist - Data Integrity / CSV

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, seeks a Specialist - Data Integrity / CSV for the Quality Control team. The role covers laboratory computerized systems lifecycle, ensuring GMP compliance and system reliability across IT and lab stakeholders.

You will drive data integrity, qualification and validation efforts, and support cross-functional projects to uphold high quality standards in a regulated environment.

Qualifikationen

• Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field; equivalent practical GMP laboratory experience may be considered.
• Experience with Quality Risk Management in accordance with ICH Q9, data and process mapping.
• Strong understanding of data integrity and data governance in GMP-lab environments.

Aufgaben

• Ensure lifecycle activities for GMP-relevant laboratory computerized systems including qualification and validation.
• Coordinate software qualification, validation, administration and lifecycle activities with QA, IT, vendors and users.
• Create, maintain and update SOPs and work instructions within the assigned area.

Kenntnisse

Analytical Reasoning

Data Analysis

Quality Control

Quality System Documentation

Compliance Management

Continuous Improvement

ISO 9001

Execution Focus

Persistence and Tenacity

Report Writing

Sample Testing

Technologically Savvy

Controls Compliance

Data Integrity

Ausbildung

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

Tools

Microsoft Office

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

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.

Here’s What You Can Expect

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & J ...

Required 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

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