Process Workstream Lead -Life Sciences
BE-BRU-Brussels
English Portal
Req #: 35608
Type: Permanent
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Overview: Expleo offers a unique offering of integrated engineering, quality and strategic consulting services for digital transformation. In a context of unprecedented technological acceleration, we are the trusted partner of innovating companies. We help them develop a competitive advantage and improve the daily lives of millions of people. Present in 30 countries and with 17,000 employees, we support our customers on a daily basis. As part of our teams, you will carry out various advisory and support missions with our clients. Joining Expleo means: * Technical support in the field Continuing training via our technical experts * Human values among our employees * The diversity of our teams An increase in skills throughout your career * Work on large-scale projects Responsibilities: What is your responsibility? * Responsible for large strategic project design technical deliverables, either developed internally or by approved 3rd party engineering service providers, ensuring adequate front-end engineering and scope development, along with overseeing the detailed design efforts to meet project requirements. * Serve as the technical anchor, act as Workstream leader for this strategic project, lead a team of process SME, and focus on project delivery. * Responsible to reach targets in terms of Project cost, schedule and functionality cost and change management. * Oversee several entities and 3rd party contractor discipline leads, e.g. Project Managers of Process integrator/ Engineering offices companies will directly report to this position. * In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations * Expert in single use systems and automation related within the pharmaceutical industry * Leading the Process & Automation team * Large experience in basic/detailed design, equipment installation and commissioning * Driving consistency within Engineering standards, norms and regulations * Ability to Lead P&ID and PFD setup is required, as well as mass balances, FS, HSD, SDS,... * Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA * Knowledge and expertise in verification ASTM E2500 * Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred. Qualifications: What are your competences? * 10+ years of relevant experience in large scale CAPEX Projects in the pharmaceutical industry * Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer), Fill and finish, autoclave and washer. * Good Knowledge of cGxP requirements * GEP - Good engineering practice expertise * Excellent communication skills (able to present to Management, Engineering office, User and others) and ability to prioritize multiple tasks and to work on multiple projects simultaneously. * Team player, Rigorous, Accountable, Involved, Proactive. * Pragmatic to solve issues; solution oriented with a positive mindset * Autonomous, fully acting at own's initiative. * Master degree in relevant field preferable
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