Based in Jumet, you will join a collaborative team, full of passionate change-makers. You will be a key member of an international and dynamic team in a fast-growing and innovative organization of 230+ people, fully supported by prominent investors and international organizations (Bill & Melinda Gates Foundation, European Investment Bank, Major impact funds…).
You will be responsible to manage Commissioning, Qualification and Validation mainly for all Univercells CAPEX projects (i.e. for Univercells Technologies, Univercells Vaccines, Unizima & Exothera) and also for regular activities.
Operationally you will report directly to the Head of CAPEX.
With your project, technical & regulatory expertise, you will strongly collaborate with process development, production process engineers, production, supply chain, quality control, quality assurance, maintenance, procurement & CAPEX teams.
Your key responsibilities will be to:
- Define the best-in-class commissioning and qualification/validation/verification practices.
- Master & apply science & risk-based approaches (QbD, DoE, Control Strategy).
- Execute or supervise CQV activities, with a focus on CAPEX projects:
- On projects: from program/project master plan, inception/feasibility/conception studies, to (Process) Performance Qualification, Cleaning & Process Validation, CSV, and with strong support during Technology Transfer, start-up & ramp-up phases.
- On regular basis: from site(s) master plans to Ongoing / Continuous Process Verification.
- Manage the CQV projects (cost, quality, time, scope, risks, expected benefits).
- Set-up, supervise, manage, train & coach CQV engineers and technicians, internal and external partners, and all stakeholders, in a disruptive & efficient way.
- Build a reliable international CQV network (suppliers, experts) and partnerships.
- Perform methodology, technology, and business intelligence on the market (Intra & cross-sector) to anticipate trends and maintain a level of expertise (QbD/PAT, big data/AI, digitalization, savings…).
- Lead continuous improvement & Operational Excellence initiatives.
- Manage EHS & Quality.
- Support regulatory and customer audits, inspections (GMP, cGMP, WHO…), and visits.
- Act as an ambassador of good project management & CQV practices awareness across the organization.
REQUIREMENTS / QUALIFICATIONS
- Engineer, MSc in Biotechnology or Process Engineering, or equivalent acquired through experience.
- 10+years of successful and relevant experience in biotech GMP activities (Viral Vectors for Cell & Gene Therapy, Viral Vaccines, Vaccines).
- Excellent track record on CQV projects, from strategy definition to execution, including fast-track/ASTM E2500 projects.
- Exposure to new plant setup & tech transfer projects is mandatory.
- Exposure to the CDMO context is an asset.
- An inspiring leader, and team player, with strong, demonstrated interpersonal skills.
- Right First Time & Customer-oriented.
- Excellent analytical and organizational skills, pragmatism, and positive critical thinking.
- Project certification (PMI, Prince2, Agile) is a clear plus.
- Resilience and agility in a demanding environment.
- Fluent in English and French.