Software Validation Specialist

Software validation specialist (SDLC methodology) / CSV Validation Specialist

Location: Beerse, Belgium - Hybrid or Remote  (We can only consider candidates who are based with in Belgium or live within 20Km of the border)

Duration: 6 months

Hours: 20 hours per week - part time 

We are seeking an experienced CSV Validation Specialist with a strong background in IT validation, specifically within the pharmaceutical or healthcare industry. The ideal candidate will have prior experience working for Johnson & Johnson and a deep understanding of the Software Development Life Cycle (SDLC) framework, along with adherence to relevant procedures such as SOP-1705.

roles and responsibilities

• Validation Planning: Develop and execute validation strategies for CSV projects, ensuring compliance with industry standards and company policies.

• Documentation: Create and maintain comprehensive validation documentation, including validation plans, protocols, and reports in accordance with SOP-1705 and other relevant SOPs.

• Risk Assessment: Perform risk assessments to identify potential validation issues and develop mitigation strategies.

• Testing: Lead and participate in the execution of CSV testing activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

• Collaboration: Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to ensure all validation efforts meet project timelines and specifications.

• Compliance: Ensure adherence to regulatory requirements (e.g., FDA, ISO) and internal compliance standards throughout the validation lifecycle.

• Training: Provide guidance and training to team members on CSV best practices and procedural compliance.

how to succeed

• Minimum of 3-5 years of experience in CSV validation, preferably in a regulated environment.

• Industry Knowledge: Prior experience working with Johnson & Johnson or similar organizations within the healthcare or pharmaceutical sectors.

• SDLC Understanding: Comprehensive knowledge of the Software Development Life Cycle (SDLC) and its application within validation processes.

• Documentation Skills: Proven ability to create detailed, compliant documentation (SOPs, validation protocols, reports).

• Analytical Skills: Strong analytical and problem-solving skills to identify issues and implement corrective actions.

Preferred:

• Bachelor's degree in a related field (e.g., Computer Science, Information Technology, Engineering).

• Familiarity with industry standards and regulations relevant to CSV (e.g., GxP, 21 CFR Part 11).

• Experience with validation tools and methodologies.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 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. 

The pay rate for this role will depend on how you are paid. 

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”.