The successful candidate will be responsible for gathering relevant master data during the detailed design phase for the HFF formulation, filling, and packaging processes. This individual will apply relevant manufacturing process knowledge to design, configure, test, train, and implement MES recipes for the Hillsboro formulation, filling, and packaging operations. The successful candidate will become an expert with the POMS.net application to enable their ability to write MES recipes this will require significant training. Corporate Engineering will support this activity and guide the successful candidate through the successful implementation and integration of the MES recipes.
A.A./B.S. degree in science or engineering discipline (B.S. preferred, Masters a plus) or equivalent experience as a QA Technical Writer. A minimum of 5 years experience in Fill/Finish in a leadership position such as Lead, Tech, or Supervisor role.
Current understanding of FDA and EMEA guidelines and cGMPs for drug products.
Team player - work well with other organizations within the project to accomplish common goals ( CIT, Corporate Automation).
Attention to detail is a strict requirement and must be able to work with minimal supervision.
Focus on the customer needs (Business, Fill Finish, Operations )
Professional level written and oral communication skills
Computer literate is a must
Must be proficient with the Microsoft suite (Word, Excel, PowerPoint) and Visio
Proficient at Web navigation / E-mail
Demonstrated project management skills
Pluses: POMS.net experience, experience with MES systems, experience with support MES hardware such as scanners, barcodes, PCs etc., SAP experience, APICS training and/or certification, experience gathering Master Data for SAP / MES Projects.
REQUISITION NUMBER: 07-1000018359