Description de fonction To strengthen our EU External Supply Integration (ESI) DP team, we are looking for a PROCESS/CLINICAL TRIAL ENGINEER to support assuring timely delivery of drug product supplies and clinical trial material from the DPDS Contract Manufacturing Organization (CMO) network.

You will support the current ESI functions who are working with Supply Chain, Procurement and Quality Assurance to assure all logistical, quality & technical elements are in place for right first time delivery of clinical material. ESI is assuring equipment/facility readiness and partner with the value streams on PF2P (Process Fit to Plant), scale-up and technology transfer.

As part of the EU ESI team, the major assignments for this challenging role covers the following:

• Support to ensure drug product supplies and assuring timely delivery of clinical trial material
• Building and implementing Key Performance Indicators & Performance Matrixes for the EU CMO network
• Support to assure all logistical, quality & technical elements are in place for clinical manufacturing at the respective CMOs
• Focus on continuous improvement and cost saving initiatives at different CMOs and locations
• Bring in process engineering expertise to support development and technology transfer of robust and lean processes at the interface towards the development organizations
• Support implementation of new enabling technologies and manufacturing platforms
• Be part of global project teams with members out of different disciplines and with different functions

Profil

• A degree (BE/MS/PhD) in chemical engineering, bio engineering, pharmaceutical technology or chemistry is preferred
• Excellent communication skills, both oral and written (Dutch and English)
• Experience in handling multiple projects in parallel
• Preferred to have understanding of new product/process introduction.
• Good understanding of ICH, cGMP, regulatory and other pertinent manufacturing and engineering guidelines and practices

Descriptif de l’organisation et du départementSelect Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis.

Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.Offre

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible.

We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.