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.
This role is responsible for providing compliance expertise, leveraging best practices, oversight and developing internal as well as external partnerships with focus on Commissioning, Qualification and Validation within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will provide day-to-day management of C&Q activities and ensure flawless liaison with the different teams, vendors, sites, and stakeholders. In addition, the role holder creates and sustains continuous procedural improvements to boost efficiency of C&Q activities. During health authority inspections and audits s/he is the first point of contact for asset qualification related matters and in a leading role to ensure successful outcomes. The ideal candidate will possess a strong track record in commissioning and qualification as well as engineering, proactive communication, and a willingness to be hands-on in key aspects of C&Q tasks.
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
- 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