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 athttps://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

QUALIFICATIONS

• Degree in bio-engineering, biotechnology or related discipline; Masters preferred.
• A minimum of 5 years of experience in bio-/pharmaceutical plant based or consultancy role
• A minimum of 5 years of proven experience as project manager/lead
• You have a good knowledge of laboratory processes and systems
• Self-driven and able to set own targets and able to 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, ISPE)
• Previous experience working in a large matrix-managed environment preferred
• Project Management certification preferred
• Previous experience with Trackwise, SAP and TruVAULT system is desired
• Fluent in English (written and spoken), Dutch language at level C1 preferred
• Proactive, open team player that recognizes Project Management as a service

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Summary

• Job TitleProject Engineer QC CAR-T
• FunctionQuality
• Sub FunctionQuality Control
• CategorySenior Analyst, Quality Control (P6)
• LocationBeerse, Antwerp, Belgium
• Date PostedOct 10 2024
• Requisition Number2406216725W