QC CSV Business Specialist

QC CSV Business Specialist

Location: Bern, Switzerland

Duration of the contract: 7 months (immediate start)

Hours per week: 40 hours

Imagine your next project standing at the forefront of data integrity, where your expertise in computerized systems ensures the highest standards of quality in life-changing healthcare innovation.

We are looking for a specialist to stand up a repeatable “archiving factory” within our QC labs. You will lead the charge in decommissioning qualified systems and ensuring that every byte of data is archived with absolute rigor and audit-readiness.

roles and responsibilities

As a QC CSV Business Specialist, you will be responsible for the full lifecycle of computerized systems within a regulated environment.

This will involve:

• Lead in Data Integrity initiatives

• Lead in decommissioning qualified/validated equipment and systems through Change Control procedures

• Lead in electronic archiving of computerized systems

• Execute equipment lifecycle activities such as periodic audit trail and user access reviews, calibration and maintenance tasks if needed

• Coordinate & manage the timely and effective completion of investigations, change controls and CAPA’s related to equipment activities

• Coordinate and drive projects regarding equipment and automated systems within the QC labs department

• Execute archiving for structured (Chromeleon/LIMS) and unstructured file systems

how to succeed

You are a meticulous professional who balances technical CSV knowledge with a proactive approach to problem-solving in a GMP environment.

You will also bring:

• Bachelor or advanced degree in Chemistry, Biochemistry, Pharmacy, or related scientific discipline.

• Sound experience in Computerized System Validation (CSV) in a GMP environment.

• Deep technical know-how of QC Lab equipment and system life cycle activities (GAMP 5, 21 CFR part 11).

• Proven experience in leading investigations and using Root Cause Analysis tools.

• Excellent communication skills in English (written and spoken).

• Ability to work self-dependently and take ownership of complex timelines.

• Experience with Chromeleon or similar CDS/LIMS systems is highly preferred.

benefits This role offers a very competitive hourly rate. This contract will run for 7 months.

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 Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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”.