Ghent, BEL
14 hours ago
Project Engineer QC, CAR-T
Change lives for the better. 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/. THE OPPORTUNITY 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 Ghent 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 including 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, including KPIs. + Actively communicates regularly with program leads and project stakeholders. + Supports the creation and update of CapEx budgets and LRFP. **Qualifications** IT’S ALL ABOUT YOU To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include: + 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 Comet, 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. Are you ready to make an impact? If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work. We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Closing date: Thursday, 27th of February 2025. Being part of Johnson & Johnson can change everything, including YOU For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. 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.
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