Process Workstream Lead -Life Sciences

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

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.

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

What’s in it for you

• Collaborative working environment – we stand shoulder to shoulder with our clients and our peers through good times and challenges
• Expleo Academy - enables you to acquire and develop the right skills by delivering a suite of accredited training courses
• Always working as one team, our people are not afraid to think big and challenge the status quo
• 20 + 12 (40hours week) days of vacation per year
• A mobility budget that can use towards your mobility or rent/mortgage
• A flexible homeworking policy

Who are we?

In this ever-evolving world, EXPLEO Belgium is an engineering and digital transformation game-changer player on the market. We are here to support our customers achieve the highest level of success in their automation, agility and sustainability journeys. We all have the same goals and are self-motivated by the same drivers.

We are EXPLEO. 

“We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age”