Commissioning, Qualification

il y a 2 semaines

Gent, Belgique Johnson & Johnson Temps plein

Are you passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium) and new build Lab’s and warehouse will be operated from the existing Janssen Beerse site. We are establishing the Engineering & Technical Services organization which will provide ownership and oversight for the entire asset portfolio and associated business processes for Janssen’s Advanced Therapies Supply Chain globally.

**Tasks and Responsibilities**:
- Ensures flawless execution of commissioning and qualification works for manufacturing and laboratory equipment as well as facilities and utilities
- Leads the writing and execution of Impact Assessments, CARA’s, IQ & OQ’s, as well as PQ’s activities and most importantly the VMP
- Owner for computer systems validation incl. writing and executing CSV protocols, FS, DS plus Functional Acceptance Test (FAT) and Site Acceptance Test (SAT), Integration testing (IQ) and Functional testing (OQ)
- Supports creation of Change Control’s, URSs, as well as FMEA’s as needed
- Drives investigations, deviations, corrective and preventive actions towards successful and compliant closure
- Assures compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
- Provide leadership and act as true expert in the field C&Q
- Manage partnerships with contractors and vendors
- Establishes and manages KPI’s and tracking tools across the scope of C&Q scope
- Actively communicates with program stakeholders on a regular basis

**Qualifications**:

- Degree in Engineering, Science, or related discipline; Masters preferred.
- 8-10 years of experience in pharmaceutical plant based or consultancy role
- A minimum of 5 years in leading commissioning and qualification activities
- A minimum of 3 years in executing commissioning and qualification activities
- Previous experience with international health authority inspections as well as internal and external audits
- Self-driven and able to set own targets and 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, FAGG/FAMHP, ISPE)
- Previous experience working in a large matrix-managed 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 with a service mindset
- Working regimen is approx. 60% Ghent, 30% Beerse, 10% travels

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