ProClinical is seeking a Project Lead Sterile on behalf of a project management and engineering company based in the Netherlands.
The project lead will be working with the department Integrated Process Team (IPT), steriles CP and/or Technical Operation (TO). The IPT steriles is from a till z responsible for the timely delivery and production of sterile endproducts. They work in a way that is in line with the internal and the external rules. This production site does high-tech bulk-production and packaging. TO will give technical support to the IPT about troubleshooting, introdiction from new products, OPEX, CAPEX and tech transfers.
- Deliver a multifuctional capital & qualification project for prefilters skids, N2 sparger and O2 measuraments.
- Set up the whole proces from purchase order until qualification.
- Coordinate that all the deliverables (URS, PO, IQ, OQ, PQ, qualification summary reports, SOP's, WI's, maintenance plans, etc) are in line with their guidelines.
- Communication with other parties within and outside of the company (quality, EHS, operations, delivery and external companies).
The production process and all equipment is very specific, of a high technical level and compiant with GMP. The Project lead needs to have a good understanding from the rules, GMP and CP building in order to do this task in the right way.
The project is done once the prefilter skids, N2 sparger and O2 measuraments are all implemented and qualified via the set budget.
- Degree within chemical technology/ mechanical engineering/ etc.
- Knowledge of CP
- Pharmaceutical experience with steriles/compounding
- Knowledge of GMP and the qualification of GMP equipment
- Lean Six Sigma knowledge is a big plus
- Speaking at least English
- Pro-active, (result)-driven
- Knows how to handle him/herself in an environment that keeps on changing and developing
- Helicopter-view: able to look and anlyse problems form different angles
- Teamplayer and teamleader
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Tooulas on +44 203 3193 032 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.