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.