Project Engineer/Lead

工作内容

Are you passionate about improving the lives of cancer patients? Our client works 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, our client 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 site. They are establishing the Asset Management / Engineering & Technical Services organization which will ensure that the entire asset portfolio and associated business processes for their Advanced Therapies Supply Chain regionally are in place, are compliant and run efficiently day-by-day.

This role is primarily responsible for leading asset related projects E2E, in addition it’s about providing technical expertise, leveraging best practices, and developing internal as well as external partnerships in the Engineering space within the CAR-T EMEA program serving the Beerse and the Ghent sites.

Responsibilities

Start by creating and sustaining continuous technical 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 in Engineering within the Pharmaceutical Sector , a flair for industrial manufacturing in a highly regulated environment plus attention to detail when it comes to Start-up, Commissioning and Qualification activities. Proactive communication, business acumen and a willingness to be hands-on in key aspects of technical tasks 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 production / laboratory equipment, facilities, and utilities engineering incl. oversight of associated works

• Ensures sound technical engineering concepts are applied in all tasks; develops, executes, and

follows through E2E technical (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

• Provides support to writing and execution of C&Q documents as well as FMEA’s as needed

• 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 Engineering or related discipline; Masters preferred.

• 6-8 years of experience in bio-/pharmaceutical plant based or consultancy role

• A minimum of 5 years of proven experience as project manager/lead

• 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

• Working regimen is approx. 60% Ghent, 30% Beerse, 10% travels