Senior Manager Project Engineering Advanced - Gent, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Tasks and Responsibilities:

Contributes to flawless execution of assigned work packages for production / laboratory equipment, facilities, and utilities related engineering/C&Q works within the CAR-T EMEA program scope.
Develops, executes, and follows through E2E technical assessments and solution implementation
Ensures that technical issues or roadblocks are anticipated and resolved as early, and as fast as possible incl. lessons learned
Provides support to writing and execution of C&Q documents, Change Control's, URSs, as well as FMEA's as needed
Drives investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
Assures compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies and corporate standards
Provides technical leadership and act as true Engineering expert for C&Q
Manage partnerships with contractors and vendors
Establishes and manages KPI's and tracking tools across the scope
Actively communicates regularly with project leads and project delivery stakeholders

Qualifications:

Degree in Engineering, Science or related discipline; Masters preferred.
610 years of experience in pharmaceutical plant based or consultancy role
A minimum of 5 years' exposure to commissioning and qualification activities
A minimum of 3 years of proven project management experience
Previous experience with international health authority inspections as well as internal and external audits
Selfdriven and able to set own targets and able to set priorities under pressure
In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.g. ISO, EN, ICH, FDA, ISPE)
Previous experience working in a large matrixmanaged environment preferred
Project Management certification preferred
Previous experience with Trackwise, SAP and TruVAULT system is preferred
Fluent in English (written and spoken), Dutch language at level C1 preferred
Proactive, open team player that recognizes Engineering as a service