Shift Lead Aseptic Manufacturing
$32,000–$45,000 year
On-site · Bedford, Massachusetts, United States
Job Summary
Shift Lead Aseptic Manufacturing role leads day-to-day aseptic floor operations for sterile drug and medical device products in ISO 5/ISO 7 cleanrooms. Acts as on-floor technical lead for troubleshooting, deviations, and ensuring batch integrity and compliance with cGMP, ISO, FDA, and OSHA standards. Responsibilities include coordinating daily manufacturing activities (dissolution, formulation, sterile filtration, filling, sterilization), overseeing environmental monitoring, maintaining documentation accuracy (batch records, logbooks, GMP forms), communicating staffing plans and shift handoffs, leading shift meetings, and driving continuous improvement. Requires strong technical leadership, cross-functional collaboration, and the ability to manage production priorities in a fast-paced, regulated environment; proficiency with ERP/SAP and ability to read complex GMP documentation; and readiness to work flexible hours and in ISO 5/ISO 7 cleanrooms.
Required Qualifications
- Bachelor’s degree in Engineering, Chemistry, Manufacturing, or a related technical discipline (or equivalent relevant experience)
- Minimum of 6 years of experience in cGMP-regulated pharmaceutical or medical device manufacturing environments
- Minimum of 2 years of experience in a lead or floor leadership role with demonstrated ability to train, mentor, and guide manufacturing personnel
- Demonstrated experience with aseptic processing operations, ISO 5 and ISO 7 cleanroom environments, aseptic manipulations, product transfers, and syringe filling operations
- Strong understanding of cGMP requirements, aseptic behavior, contamination control, and cleanroom operations
- Experience with Material Requirements Planning (MRP) systems, including production planning and material transaction execution
- Ability to read, interpret, and execute complex batch records, SOPs, and GMP documentation with strong attention to detail
- Experience operating automated or semi-automated filling equipment within aseptic manufacturing environments
- Strong communication, organizational, and troubleshooting skills with ability to work collaboratively across functions
- Proficiency with Microsoft Office applications and ERP systems such as SAP or similar manufacturing systems
- Ability to work flexible hours to support manufacturing operations and production schedules
- Ability to work within ISO 5 and ISO 7 cleanroom environments while wearing full aseptic gowning and required PPE for extended periods
- Ability to lift, pull, or push equipment up to 25–50 pounds, stand for extended periods, climb ladders/platforms, and work around manufacturing chemicals
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