BE - Commissioning and Qualification Engineer

Are you thinking about old problems in new ways? Passionate about making an impact? Then you belong at J&J! Johnson & Johnson is working with the latest in technology in order to change the trajectory of human health. Join us and help us improve the health across the world, every day.

Your responsibilities and your Impact:

Supports the C&Q group in providing documented evidence that all equipment and utilities used in/by/for JSC are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and business specifications

Key responsibilities:

• Technical and function specific tasks and responsibilities · Provides business support as technical owner (questions, technical issues), when requested

• Makes detailed assessments for the projects, changes, modifications, good practices, corrections, remediations, break-downs, non-compliance issues, investigations etc assigned to him/her by the C&Q lead.

• Passes on requests made to C&Q team to C&Q lead

• Takes part in the core team / planning meetings of projects, etc assigned to him/her by the C&Q lead

• Keeps Kanban cards (work overview) up to date of projects, etc assigned to him/her by the C&Q lead · Asks for support or information from C&Q lead when needed.

• Involves C&Q lead for escalation when needed

• Enters assessments and completed tasks in Trackwise

• Reviews and approves qualification documents written by qualification engineers (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR)

• Works together with the QA qualification team to get qualification files approved

• When packaging activities are leveraged for qualification purposes, reviews and approves the packaging line trial before execution and the documented line trial

• Initiates and follows-up QI?s and corrections in Trackwise when needed for projects, changes, etc assigned to him/her by the C&Q lead

• Contributes to C&Q team internal improvement projects

• Assists the C&Q lead in preparing for and providing support during internal and external inspections and assists the C&Q lead in maintaining the area Validation Master Plans, containing an inventory of all existing systems and their qualification status.

• Assists the C&Q lead in performing periodic assessments (PSQR) of the overall quality of GMP critical systems and deciding upon the need for re-qualification.

• Assists the C&Q lead in providing introductory qualification trainings (LDO)

• Acts compliant with GMP requirements · Based on expertise, maintains a current knowledge of international regulations, guidelines and industry practices related to system (process equipment) qualification

• Based on expertise, identifies gaps in procedures, qualification files or existing systems and alerting C&Q lead.

• Strives for high quality equipment qualification files · Identifies quality catches and Kaizen opportunities and reports them to C&Q lead

• Serves as coach to qualification engineers · Gives feedback to qualification engineers regarding quality of work delivered · Based on experience, supports training to new team members (onboarding), when requested

Education and Experience Required for Role

Essential:

• Minimum 5 years experience in commissioning, qualification and validation, preferably in a pharmacuetical environment.

• Dutch and English speaking.

• Must be available to come on site to Beerse 4 days out of 5.

• Ability to interact at different levels of the organization.

• Ability to work under pressure, handle conflicting interests, and take decisions.

• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly

• Problem solving skills and attitude

• Project Management - provide timely and accurate reporting on project activities to peers and leadership.

• Bachelor degree or higher in engineering, biotech, biomedical sciences or pharmacy is required

• Strong working knowledge of current Good Manufacturing Practices (cGMP)

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that 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 in Belgium 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”.