Johnson & Johnson
Project Manager
Project Manager
Location: Gent, Belgium
Duration: Contract wil run untill June 2027
Hours: 40
Imagine your next project driving critical qualification and compliance activities as a C&Q Engineer / Project manager, directly supporting life-changing CAR-T processes and ensuring cutting-edge equipment and utilities consistently operate in a validated, compliant state of control.
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.
roles and responsibilities
Is responsible for the coordination of qualification activities assigned to them
Is responsible for technical content of Equipment Qualification files assigned to them
Acts as a Technical Owner within JSC CAR-T Organisation
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 them 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 them by the C&Q lead
Keeps status of projects, etc assigned to them by the C&Q lead
Asks for support or information from C&Q lead when needed, and involves C&Q lead for escalation when needed
Enters assessments and completed tasks in Trackwise
Communicates with the involved departments regarding test planning, test materials, resources, etc for projects, etc assigned to them
Supports in the evaluation of project issues and changes towards impact on approach of qualification activities (f.e. deviations from protocol, scope changes)
Ensure qualification activities are performed in a qualitative and timely manner (within reasonable expectations)
Reviews and approves qualification documents written by other C&Q 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
Reviews the executed qualification tests documented by other C&Q engineers or other testers
Initiates and follows-up QI’s and corrections in Trackwise when needed for projects, changes, etc assigned to them by the C&Q lead
Own and manage C&Q processes together with other C&Q engineers and the C&Q lead (aVMP, Periodic reviews, change evaluation, L4L evaluation, qualification etc…)
Contributes to C&Q team internal improvement projects
Support during internal and external inspections
Assists the C&Q lead in providing introductory qualification trainings
Supports and is backup to other C&Q SME’s when needed
Before long absences, makes sure handover is done for relevant qualification activities
Reports activities consistently and correctly in JnJ timesheet
Acts compliant with GMP requirements
Strives for high quality equipment qualification files
Identifies quality catches and Kaizen opportunities and reports them to C&Q lead
Strives to complete all mandatory trainings within their due date
Serves as process owner
Gives feedback to other C&Q engineers about the quality of work
how to succeed
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
Based on experience, supports training to new team members (onboarding), when requested
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 or LinkedIn InMail - you must apply direct to this advert.
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”.