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

QUALIFICATIONS

We would love to hear from you, if you have the following essential requirements:

• Degree in Engineering, Science, or related discipline; Masters preferred.
• 3-5 of experience in pharmaceutical site based or consultancy role
• A minimum of 3 years in leading C&Q or CSV activities
• A minimum of 3 years in executing CSV 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
• Depth knowledge of current GMP standards and GAMP guidelines related to computer systems (e.g., 21 CFR part 11; EU GMP Annex 11, Data Integrity, ISA-88 Standards for Process Control / ISA-95 Standards of Automated Interfaces, ICH, FDA, FAGG/FAMHP, ISPE)
• Previous experience working in a large matrix-managed environment preferred
• Project Management certification preferred
• Previous experience with Quality Event Management Systems, SAP and TruVAULT system is preferred
• Fluent in English (written and spoken), Dutch language at level C1 preferred
• Working across project sites in Ghent and Beerse as required

What type of mark will you make?

By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson&Johnson means that “YOU belong”!

For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.

Summary

• Job titleLead Engineer Computer Systems Validation
• FunctionSupply Chain Engineering
• Sub functionQuality Engineering
• CategoryExperienced Engineer, Quality Engineering (ST5)
• LocationGhent, East Flanders, Belgium
• Date postedOct 30 2024
• Requisition number2406191490W