Johnson & Johnson
Quality Assurance CSV Engineer
Quality Assurance CSV Engineer
Location: Beerse, Belgium
Duration: End of 2025 (Possibility of extension)
Hours: 40 (Hybrid working - 3 days a week onsite)
roles and responsibilities
Assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.
Review and approve CSV documents such as SOPs, user requirements, impact/risks analyses, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines, J&J and Janssen policies and standards.
Be part of IT/engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
Address and follow-up of deviations occurred during execution of CSV activities.
Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality.
Provide periodic reports on quality system compliance.
Prepare for system audits and inspections.
Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives.
Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV. Implement this knowledge to maintain and improve Computerized Systems Validation.
how to succeed
Knowledge of cGMP’s: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.
Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).
Knowledge of SW development and testing processes.
Knowledge of Quality auditing
Knowledge of Software quality metrics
Ability to multi-task and work on a variety of projects at one time.
Ability to work independently and work in cross-functional team environment.
Good communication skills, good project management skills, good problem solving skills.
QA experience
benefits
This role offers a very competitive hourly rate. This contract will run until the end 2025 (extension is possible).
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”.