Lead Engineer Computer Systems Validation

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, Johnson & Johnson 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 Johnson & Johnson Beerse site.

We are establishing the Asset Management / Engineering & Technical Services organization which will ensure that the entire asset portfolio and associated business processes for Janssen’s Advanced Therapies Supply Chain regionally are in place, are compliant and run efficiently day-by-day.

What you will be doing:

In this role you will provide compliance expertise, leverage best practices, oversight and develop internal as well as external partnerships with focus on Computer System Validation within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will provide day-to-day management of CSV 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 CSV activities. During health authority inspections and audits s/he is the first point of contact for computer validation related matters and in a leading role to ensure successful outcomes. The ideal candidate will possess a strong track record in commissioning and qualification, especially CSV, as well as engineering, proactive communication, and a willingness to be hands-on in key aspects.

What impact will you also have:

You will get an opportunity to utilize your strong track record in Computer System Validation to help deliver life-saving treatment to cancer patients.

In your day-to-day job you will:

• Ensures flawless execution of CSV works for manufacturing and laboratory equipment and as needed also for facilities and utilities


• Leads the writing and execution of Impact Assessments, CARA’s, qualification documents according to GAMP requirements and most importantly the associated 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


• Ensure compliance in the field of Process Automation engineering (Levels 0-2); OSI-PI, Equipment PLC, SCADA, IDP (Instrument Data Platform), Middleware, and integrations with MES (Level 3)


• Provide leadership and act as true expert in the field of CSV


• Support or act as Technical Business/Process Owner for the site's PI Data Historian


• Manage partnerships with contractors and vendors


• Establishes and manages KPI’s and tracking tools


• Actively communicates with program stakeholders on a regular basis