TECHNICAL AND SOFT SKILS
Strong knowledge of core principles in various engineering disciplines including API production (drug substance), drug
* Experience with verification, qualification & validation (both V-cycle and ASTM E2500 approaches) 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 PED (Pressure Equipment Directive) is an 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) Equipment installations & Commissioning experience Coordinate multi project in parallel