Lead Operator

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.

• 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
  .