Project Engineer QC CAR-T

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

CAR-T is an innovative blood cancer treatment that uses the strength of the patient’s own immune system. The patient’s T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site. We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The Innovative Medicine Supply Chain Group, a member of the Johnson & Johnson family of companies, is therefore recruiting a project engineer for the QC CAR-T hub in Europe. The position will be based in Beerse Belgium.

This role is primarily responsible for leading QC related projects E2E, in addition it’s about providing technical expertise, leveraging best practices, and developing internal as well as external partnerships in the QC space within the CAR-T EMEA program serving the Beerse and the Ghent sites. Responsibilities start by creating and sustaining continuous improvements within the scope of the program to boost efficiency of assigned projects and ensure schedule and budget adherence. The ideal candidate will possess a strong track record in project management within the Pharmaceutical Sector, an interest for industrial manufacturing in a highly regulated environment plus attention to detail. Proactive communication, business acumen and a willingness to be hands-on are key to ensure mission success along the project lifecycle.

Tasks and Responsibilities include:

• Project leadership, including obtaining agreement on project definitions and priorities and ensuring that resources, capabilities, and processes are in place to flawlessly execute assigned projects for laboratory equipment, facilities, and utilities engineering incl. oversight of associated works
• Develops, executes, and follows through E2E feasibility assessments and solution implementation
• Writing of all required documents along the project lifecycle, such as business cases, capital appropriation requests, project execution plans, change controls, URSs, plus periodic status reports and ultimately lessons learned
• Ensures compliance with all applicable cGMPs, local codes and standards, regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
• Ensures projects stay on plan by resolving conflicts and removing obstacles, which may involve negotiations at a senior level within the business, stakeholders and/or vendors
• Acts as project leader/core team member by tracking and following up on cost, issues, quality and schedule ensuring an effective management of project execution, incl. KPI’s
• Actively communicates regularly with program leads and project stakeholders
• Supports the creation and update of CapEx budgets and LRFP

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