Manufacturing Engineer - ACL Digital

Title: Senior Engineer

Location: Thousand Oaks, CA

Duration: 12 months

Technical Skills: Drug product fill finish processing, Holistic DP process knowledge.

Technical transfer, drug product manufacturing, regulatory filings.

Description:

Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.

• Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.

• Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.

• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.

• Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.

• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.

• Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions

• Identifies and implements operational opportunities for current and new sterile operations.