Quality Assurance Qualification Engineer

Quality Assurance Qualification Engineer

Location: Geel belgium, hybrid 3 days a week

Duration: 12 months

Hours: Full time

Imagine your next project supporting the QA Engineering department at a global leader in innovative medicine, ensuring vital manufacturing systems meet the highest regulatory standards throughout their entire life cycle.

General Service Support the QA Engineering department at J&J Geel in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel manufacturing systems.

roles and responsibilities. Support the QA Engineering department at J&J Geel in assuring that all Qualification related regulatory and procedural requirements are fulfilled. This will involve:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc…) in order to maintain compliance to regulations, guidelines, and J&J policies and standards.

• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.

• Address and follow-up of deviations occurred during execution of qualification activities.

• Communicate status (quality&compliance, planning,…) towards J&J QA Qualification team members.

how to succeed.

You will bring experience in the chemical and/or pharmaceutical industry with respect to qualification of equipment and a strong knowledge of cGMP regulations and guidelines. You will also bring:

• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.

• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.

• 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.

• Fluent in English & Dutch (written and spoken)

• Specific know how of manufacturing systems used within pharmaceutical or chemical industry.

• Specific know how of problem report, change request systems. (f.e. Trackwise, Comet)

• Specific know how of Document Management systems (f.e. TruVault)

• Specific know how of Test tools (f.e. Kneat)

benefits.

This role offers a very competitive hourly rate. This contract will run for 12 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 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 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”.