My client is a world-leader in the Pharmaceutical Industry
Commissioning & Qualification Engineer
Length: 7 months - possible extension
Start: Around 1st of May
- Ability to identify and escalate issues within an organized Tier structure.
- Technical background in facility and mechanical system engineering, familiar with working in GxP environments, experience with Vaporized Hydrogen Peroxide (VHP) system designs and testing, sprinkler systems, black utilities such as chilled water, process cooling water, plant steam, potable water and with cleanroom facility design and testing.
- Proven experience as a Commissioning engineer, having experience with end-of-construction, mechanical completion, pre-commissioning activities and leading commissioning activities of aforementioned systems.
- Reviewing Qualification documents: CCR, SAT, IOC, IOQ (Construction Completion Records, Site acceptance Testing, Installation and Operational Commissioning and where applicable Qualification reports) for the sprinklers, black utilities, VHP and Clean Rooms. This review is a technical review to make sure that the list of tests and the acceptance criteria match GES standards.
- Reviewing hand-over documents: TOP (turnover package) binder reviews including CCR/SAT/IOC/IOQ reports. This is a technical review to ensure GES standards are being met.
- Witnessing Qualification activities: Some critical tests as the pressure tests (ductwork and cleanrooms), VHP (Vaporized Hydrogen Peroxide) cycle development, Room airtightness tests and the walkdowns with construction management, contractors and stakeholders
- Working well together with project management, process lead engineers, facility lead engineers, construction management, contractors, safety engineers.
- Familiar with industry procedures relating to cGEP (Good Engineering Practice) during Start Up
- Knowledge of cGDP (Good Documentation Practices)
- Knowledge of IQ/OQ principles
- Responsibility for Safety of commissioning for the Systems involved
- Minimal 5-8 years relevant commissioning/start-up experience
- Proactive, Self-starter and Capable of Working alone or in a team environment
- Proven ability to lead a technical orientated team
- Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
- Willing to work flexible hours (including possibility of shift and other schedule retrieval methods) and weekends in line with schedule requirements
- Fluent in Dutch and English
- Full time position
- Full time attendance on site required
- Go see mentality