Description:
- Serve as an 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.
Top 3 Must Have Skill Sets:
Drug Product manufacturing experience
Aseptic Compliance/Contamination Control Knowledge
Outstanding communication skills
Day to Day Responsibilities:
Providing on the floor support during aseptic operations
Developing metrics, actionable outputs, and managing completion of those outputs
Revising controlled documents to support changes and improvements
Own aseptic related deviations