Description
The company
The Harvey Nash Group was founded in the UK in 1988, and now has offices throughout Europe, America and Asia. The Harvey Nash Group is known for the thousands of successful assignments completed throughout the world.
From more than 39 offices, and with 5000 staff and associates, we offer a unique range of consulting recruitment specialising in IT recruitment, benefits subcontracting and outsourcing services to our clients. Our departments of Executive Search and Interim Management support our customers around the world by placing the senior managers essential to business growth and effective management.
For one of our clients, we're looking for a "GTS Bulk Engineer".
Summary:
As a member of the Global Technical Services of the client's Bio in all Bulk projects (existing facilities upgraded and new facilities), the selected candidate will be responsible for:
The definition of the needs (URS) up to the commissioning and qualification of Downstream Bulk Equipment in accordance with the client's procedures for URS, DQ, FAT, SAT, IOQ and Hand-over.
Bulk Downstream equipment included: Chromatography Controllers & columns, Ultra-Filtration skid, Centrifuges, Filtration,
Essential Functions:
The position includes responsibility for all or part of the following steps:
*Determination of equipment specifications with users representative & write the URS
*Analyse technically the offers from different suppliers & select the preferential supplier with procurement team based on decisional matrix predefined.
*Following the detailed design and construction of the equipment
*Tests coordination with the project manager, the users, validation team, engineers and other disciplines associated with the project
*Travel to supplier to perform FAT
*Preparation and execution of the qualification protocols IO/OQ or IV/OV (ASTM2500), in collaboration with users and validation team
*Training of operations and maintenance workforce for hand over
*Support during the PQ
Profile:
*An Engineer qualified in Chemical Engineering, Process Engineering, Biochemistry, Mechanical Engineering discipline
*Minimum of 5 years experience in the pharmaceutical industry, engineering contractors
*Experience of qualification and validation techniques and cGMP requirements
*Capable of working as part of a multidisciplined team as well as an individual
*Good organizational skills and ability to manage their time and identify priorities
*An analytical, logical and practical person
*Good reactivity when facing challenges such as changes in schedule or in users requirements
*Rigorous in following documentation and the project stages in accordance to the client's requirements
*Flexible for travel on occasional assignments, sometimes overseas
*A working knowledge of written and oral French and English.
Contract Time:
*The first contract duration is a 3 months contract and after this, it can be extended depending on the needs.