C&Q Engineer
East Flanders
Life Sciences - Validation and Qualification
Bachelor, Master
Work experience: 3-5
Reference number: 90636
Key Responsibilities:
- Is responsible for the technical content of Equipment Qualification files assigned to him/her.
- Acts as a Technical Owner within the JSC CAR-T Organisation.
- Provides business support as Technical Owner (questions, technical issues) when requested.
- Makes detailed assessments for projects, changes, modifications, good practices, corrections, remediations, breakdowns, non-compliance issues, investigations, etc. assigned by the C&Q Lead.
- Passes on requests made to the C&Q team to the C&Q Lead.
- Takes part in core team and planning meetings of projects assigned by the C&Q Lead.
- Keeps status updates of projects assigned by the C&Q Lead.
- Asks for support or information from the C&Q Lead when needed and involves the Lead for escalation when required.
- Communicates with involved departments regarding test planning, test materials, resources, etc. for assigned projects.
- Supports the evaluation of project issues and changes to assess their impact on qualification activities (e.g., deviations from protocol, scope changes).
- Reviews and approves qualification documents written by other C&Q engineers (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR).
- Reviews executed qualification tests documented by other C&Q engineers or testers.
- Contributes to internal improvement projects within the C&Q team.
- Provides support during internal and external inspections.
- Assists the C&Q Lead in providing introductory qualification trainings.
- Supports and acts as backup to other C&Q SMEs when needed.
- Ensures proper handover of relevant qualification activities before long absences.
- Reports activities consistently and correctly in the J&J timesheet system.
- Enters assessments and completed tasks in COMET.
- Owns and manages C&Q processes together with other C&Q engineers and the C&Q Lead (aVMP, periodic reviews, change evaluation, L4L evaluation, qualification, etc.).
- Initiates and follows up QIs and corrections in COMET when needed for projects or changes assigned by the C&Q Lead.
What are we looking for?
- Education:
- Technical or scientific degree.
Years of Experience:
3–5+ years of relevant experience.
Industry Experience:
Experience in the pharmaceutical industry is a significant advantage.
Other Skills Required:
Proven experience in equipment qualification and validation.
Experience reviewing technical documentation such as URS, risk assessments, traceability matrices, test protocols, and reports.
Ability to act as a technical SME to guide and ensure compliance of execution teams.
Language Skills:
Dutch and English.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
)
