Periode: Project duration for at least a year
For a huge project to be expected in 2018 we are keen on staffing the right people for the project to start.
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
We are looking to recruit a hands-on C&Q engineers with experience and track record within the pharmaceutical industry.
Design, develop, execute and write IQ/OQ/PQ validation protocols and reports according to standards and guidelines for the pharmaceutical industry. Field execution of commissioning and qualification activities including construction walkdowns, review of construction dossiers, start-up and commissioning of plant systems. Validation review of vendor, contractor documents as required. Archive the relevant reports. Closure and report generation for qualified systems. Analyze and interpret validation data, results and summarize findings in final reports. Analyze the design to identify the GMP requirements for validation. Resolve protocol and execution discrepancies to a satisfactory conclusion and plan follow up actions as required. Make recommendations and decisions (when appropriate) regarding test strategies and approaches. Conducting and coordinating validation testing
Education: Chemical engineering or mechanical engineering (bachelor or masters degree,
HTS or TU) or other relevant education and 5 - 10 years relevant experience
Required qualifications and skills:
- Hands on commissioning and qualification experience
- Experience in project start-ups
- Significant Experience in C&Q
- In depth knowledge of GMP
- Experience in writing, executing, and summarizing validation protocols and SOPs
- Knowledge of validation regulatory and industry standards and guidelines
- Team player, but also able to work independent
- Anticipating attitude (is a must)
- Fluent in spoken and written English (Dutch is a preference)