The Senior Process Investigator, part of the PDTS (Process Development and Technical Services) organization, is a support function for the Biologics and Plasma Operating Units, providing technical and methodological leadership for complex and/or high impact process/product investigations, following Advanced Problem Solving and 6-sigma methodology.
In addition, he/she provides methodological and technical support to the Biologics plants/network for large cross-products/cross-sites process improvements, and operational efficiency initiatives related to robustness/yield/efficiency increase across the network.
Key to this function is to efficiently coach, drive and leverage the dedicated local technical support and global product support teams to achieve their goals.
Provide technical and methodological leadership for complex and/or high impact process/product investigations.
Define, deploy and continuously improve a standard problem solving methodology for process investigations. Own the business process and establish the operating mechanisms.
Drive alignment of best manufacturing practices across BioOpU taken from investigations or process improvements.
Stay current with and share across Shire Biologics OpU the industry/academia best practices relevant to biopharmaceutical manufacturing
Implement and maintain a knowledge database for investigation root causes, and pro-actively address vulnerabilities and common causes of issues.
Support identification and execution of cross-products/cross-sites process improvements
Drive harmonization, implementation of best practices and knowledge sharing through a community of practice/center of excellence for Biologics (local PKC coordinators, QbD team)
Provide technical training to TS organization to ensure high quality of local manufacturing support
EDUCATION AND EXPERIENCE
Minimum Degree Required: Science or Engineering Bachelor's Degree
Preferred Degree: Master/PhD
Bachelor degree in technical / scientific education, preferably biochemistry, biotechnology or pharma - process engineering is essential .
With a Bachelor's degree, at least 10 years professional experience in a similar role in the field of Technical Operations, Process Management or Development, Manufacturing within the pharmaceutical industry, preferably biotechnology.
6-sigma certified (Green or Black-Belt) with demonstrated experience in Technical Problem Solving.
Prior experience of managing global teams in a matrix is preferred.
Travel Requirements: Up to 50% of time
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.