Website OneSource Consulting
Job Title: Project Lead
Location: Braine l’Alleud, Belgium
Languages: French & English
Minimum 5 years of relevant experience in Project Engineering in
TECHNICAL AND SOFT SKILS
Strong background within manufacturing equipment (autoclave, UF/MF filtration skids, Chromatography skids,
CIP/SIP, washing machine) and support systems (e.g. WFI, PW, clean steam, compressed gases)
Experience with EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and
Construction Management) contracting models is an asset
• Knowledge in different qualification & validation approaches (both V-cycle and ASTM E2500) is an asset
• Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required
• Ability to lead & review ATEX & PED (Pressure Equipment Directive) is a important asset
• Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
• Experience in large and complex projects as well as both formal and informal leadership / coordination
• Ability to share good practices and knowledge
• Can identify latest trends in the industry
• Can benchmark against peers in the industry
• Excellent communication skills (able to present to Management) and ability to prioritize multiple tasks and to work on multiple projects simultaneously.
• Strong technical skills and the ability to explain complex issues and requirements in an easily understood manner.
• Ability to apply previous learning and ideas to new situations, projects and teams, developing creative solutions to manage risk to a reasonably practicable level.
• Ability to communicate effectively and make presentations with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Able to both take direction and mentor other team members
• Able to translate customers’ needs in technical requirements
• Demonstrated verbal and written communication skills and the ability to compose correspondence and reports
• Full professional proficiency in French and English (both oral and written)