Proclinical has partnered with a Global Parenterals Technical Operations team to recruit for a Process Engineer to support a Technical Owner (TLI). Technical Operations is providing product & process centred technical support for the Parental manufacturing network, as well as playing a pro-active role in Innovation and Standardization.
- Tech Transfer (TT) for New Product Introduction (NPI) for Drug Product manufacturing for both internal and external manufacturing facilities, but mainly focused on the German site and regional Contract Manufacturing Organizations (CMO's).
- Support for the Parenteral Centre of Innovation (PCI) and taking and an active role in global alignment and standardization of processes and procedures.
- Providing active support for products sourcing, Business Case development and general technical / operational programs.
- Interface with manufacturing organization and the Process Development (PD) organization
- Interface with QA, RA, Engineering and other key business partners to ensure flawless process transfer
- Monitor technical process and product performance, develop models and metrics to ensure production consistency, and regulatory compliance
- Lead or support complex failure investigations
Skills and Requirements
- At minimum a Bachelor's degree in a numerate discipline - engineering or science
- Experience in a pharmaceutical environment is required, preferably over 5 years or more
- Knowledge of Quality & Compliance, GxP systems, and knowledge of validation is required
- Experience in project management (FPX or similar), organizing, planning and coordination skills are required
- Knowledge of regulatory requirements (GMP/EH&S) is preferred;
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 contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.