Specialist - Data Integrity / CSV

8562-Cilag AG Legal Entity; Schaffhausen; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Benefits dieser Stelle

Global company

Schaffhausen location

Inclusive work culture

Zusammenfassung

Johnson & Johnson in Schaffhausen seeks a Specialist for Data Integrity / CSV (80-100%). You will manage lifecycle activities for laboratory computerized systems, coordinating qualification, validation and documentation with QA, IT and vendors.

Strong GMP data integrity knowledge is essential; English is required and German is a plus. This role offers a collaborative environment with opportunities to influence quality systems and compliance.

Qualifikationen

• PhD, Master or comparable in natural sciences, computer science, engineering or related field with GMP/CSV/data integrity experience.
• Experience with GMP-lab software qualification, validation and lifecycle activities.
• Strong knowledge of data governance and quality systems in regulated environments.

Aufgaben

• Owns lifecycle activities for laboratory computerized systems including validation, qualification and documentation.
• Coordinate software qualification/validation with QA, IT, vendors and stakeholders.
• Develop and maintain SOPs/work instructions; support cross-functional projects and CAPA actions.

Kenntnisse

Analytical Reasoning

Data Integrity

Quality Control

Documentation

GxP Compliance

CAPA Management

ICH Q9

Communication

English Proficiency

German Knowledge

Ausbildung

PhD / Master in natural sciences or related

Tools

CSV validation tools

Laboratory IT systems

Windows administration

Jobbeschreibung

Job Opening

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

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Professional

All Job Posting Locations

Schaffhausen, Switzerland

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

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.

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 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 https://www.jnj.com/.

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

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 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 https://www.jnj.com/.