Quality Engineer CSV

Quality Engineer CSV

Location: Schaffhausen, Switzerland 

Duration:12 months contract role (hybrid working - 2 days home office, 3 days onsite)

Hours: 80% or 100%

Essential: English & German mandatory, previous pharmaceutical or medical device experience, CSV and GMP required.

Imagine your next project shaping manufacturing innovation in a global company at the forefront of healthcare with an accessible location in beautiful Schaffhausen.

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 QA Quality Engineer / CSV who will be responsible for the lifecycle management of computerized systems in the manufacturing area, ensure data integrity, and maintain compliance with CSV and governance standards. Join our Site Quality Control team in Schaffhausen and make a global impact on patients’ lives.

roles and responsibilities 

The QA Quality Engineer / CSV will be responsible for the lifecycle management of computerized systems in the manufacturing area, ensure data integrity, and maintain compliance with CSV and governance standards. This will involve:

Manufacturing Systems & Software Qualification:

• Ensure GMP and regulatory compliance for qualification activities of production systems

• Review and approve qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, interface qualification, Audit Trail review) for production systems

• Review and approve procedures (WIs, SOPs) related to data integrity and lifecycle management of production systems

• KNEAT experience (digital qualification tool)

Data Integrity & Governance:

• Review and approve requirements for new software solutions and analyze data and process flows within the production environment

• Review and ensure strategies for security, backup, and recovery for computerized production systems (e.g., databases)

• Approve archiving or migration of legacy system data as part of lifecycle management

• Investigate and assess data integrity issues and software non-conformities (NC, CAPA) in compliance with GMP and regulatory standards

Cross-functional Collaboration:

• Support and coordinate teams (e.g., Production, IT, Quality Assurance) in the area of complaints to ensure seamless integration of production systems and data workflows.

• Ensure structured communication on requirements, system changes, and troubleshooting to improve interaction between teams.

how to succeed 

You will have an M.Sc. in Natural Sciences, Computer Science, Engineering, or related field (Alternatively: Bachelor’s degree or equivalent vocational training combined with several years of relevant experience in a GMP environment) and proven work experience in GMP-regulated environments (preferably Quality Control). You will also bring:

Required Skills & Experience:

• Strong analytical and problem-solving skills

• Experience with CSV qualification approach (ISPE standard)

• Fluent in German and basic spoken English skills (B1 or above desirable)

Preferred Skills & Technologies (advantageous but not required):

• Hands-on familiarity with manufacturing systems qualification, CSV, SCADA, or virtualization

• Experience with MES, OSI-PI, SAP, TrackWise, or TruVault

• Ability to convey technical material to non-specialists

What We Offer:

• Collaborative, inclusive work environment that values work-life balance

benefits 

This role offers a very competitive hourly rate. 

you are welcome here 

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.