Fully onsite ATO
Please note working hours below (24/7 operations begins April 2027)
Copy of AMAGJP00015813, no resubs of rejected candidates
Candidates must have experience with aseptic practices and drug product filling. Suppliers must screen for this experience beyond familiarity
- Serve as a drug product aseptic processing technical resource supporting 24/7 drug product manufacturing. The role will begin with M-F 8-5pm, but transition to Wed-Sun 8-5pm once 24/7 operations commences in 2027.
- Support continuous improvement initiatives that strengthen aseptic compliance, process robustness, and operational efficiency.
- Revise controlled documents, including SOPs, work instructions, and related records, to support process changes and improvements.
- Own aseptic related deviations.
Support the 24/7 Ways of Working Lead to evaluate 1+ year of aseptic call log data from the floor and identify recurring trends, root causes, and improvement opportunities.
- Develop clear metrics, summaries, and actionable outputs that convert operational data into decisions, priorities, and follow-up actions.
- Establish and maintain a cyclic process for gathering information, addressing challenges, implementing improvements, and assessing effectiveness.