- Act as the aseptic subject matter expert on the manufacturing floor, supporting operators during day-to-day aseptic processing activities.
- Work closely with the team to identify and prevent potential contamination risks, deviations, or process failures before they occur.
- Support the team in improving aseptic technique, environmental awareness, and operational discipline within ISO classified cleanroom environments.
- Provide hands-on coaching and guidance to operators to strengthen competency and consistency across the team.
- Assist in investigating and addressing operational issues, particularly related to sampling practices and recovery following events or interventions.
- Drive continuous improvement initiatives to enhance aseptic performance, reliability, and compliance with cGMP standards.
- Act as a technical leader on the floor, working alongside production rather than managing from an office environment.
- Strong experience working as an Aseptic Operator within pharmaceutical, biologics, or sterile manufacturing environments.
- Deep understanding of aseptic processing, contamination control, and cleanroom operations (ISO classified environments).
- Demonstrated ability to identify operational risks and improve aseptic practices on the manufacturing floor.
- Experience supporting media fills, interventions, sampling practices, and deviation recovery activities.
- Strong communication skills with the ability to coach and influence operators in a hands-on environment.
- Passion for continuous improvement and maintaining high standards of aseptic compliance.
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Job Title: Aseptic Operator (Aseptic SME / Floor Lead) · Location: Bedford MA · Shift: Monday – Friday | Day Shift · We are supporting a leading Life Sciences manufacturing organization that is looking to bring in a highly experienced Aseptic Operator to act as a hands-on technic ...
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Lead Operator - Bedford - i-Pharm GxP
Description
Job Title: Aseptic Operator (Aseptic SME / Floor Lead)
Location: Bedford MA
Shift: Monday – Friday | Day Shift
We are supporting a leading Life Sciences manufacturing organization that is looking to bring in a highly experienced Aseptic Operator to act as a hands-on technical leader on the manufacturing floor.
This is not a people management role. Instead, the focus is on bringing in an experienced aseptic operator who can act as the subject matter expert within the cleanroom, supporting the team, identifying issues early, and helping drive improvements in aseptic practices and process reliability.
The site has identified specific opportunities for improvement around sampling practices and recovery following events, and they are looking for someone who can work directly with operators to strengthen capability, awareness, and execution in these areas.
Key Responsibilities
Requirements
What This Role Offers
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Lead Operator
Only for registered members Bedford
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Operations Lead
Only for registered members Waltham
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Operations Lead
Only for registered members WALTHAM, MASSACHUSETTS, UNITED STATES
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Lead Modeling and Simulation/Operations Research Analyst
Only for registered members Bedford
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Engineering Operations Lead
Full time Only for registered members Woburn
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Communications & Operations Lead
Full time Only for registered members Wilmington
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Communications & Operations Lead
Only for registered members Wilmington
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Engineering Operations Lead
Only for registered members Woburn, MA
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Sr. Director, Compound Operational Lead
Only for registered members Billerica, MA
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Operational Ex Lead
Only for registered members Woburn, MA
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Operational Ex Lead
Only for registered members Woburn, MA, United States
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Communications & Operations Lead
Only for registered members Wilmington, MA
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Quality Operational Excellence Lead
Only for registered members Billerica
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Quality Operational Excellence Lead
Only for registered members Billerica, MA
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Lead Modeling and Simulation/Operations Research Analyst
Only for registered members Bedford, MA
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Sr. Director, Compound Operational Lead
Only for registered members Billerica
-
Operations Lead
Full time Only for registered members Lynnfield
-
Developer Operations Lead
Only for registered members Weston, MA, USA, Weston, MA
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Operations Lead
Only for registered members Lynnfield, Massachusetts, United States
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Operations Lead
Only for registered members Peabody