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Sterile Compounding Laboratory Technician

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Beacon Hill

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Location:
United States , Lexington

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Sterile Compounding Laboratory Technician supports sterile drug product manufacturing by performing aseptic compounding, solution preparation, equipment setup, and controlled cleanroom activities in compliance with cGMP, site SOPs, and applicable regulatory requirements. This role executes batch record steps, performs line and room clearances, supports environmental monitoring, and maintains cleanroom readiness to ensure consistent, high-quality sterile product output.

Job Responsibility:

  • Prepare sterile and non-sterile solutions (buffers, media, intermediates) using validated procedures and aseptic technique
  • Perform weighing, staging, and compounding activities (e.g., mixing, pH adjustment, filtration preparation) per approved batch records
  • Execute sterile filtration steps (as applicable), component preparation, and material transfers using proper gowning and cleanroom behaviors
  • Support aseptic processing operations including setup/tear-down of compounding areas and related equipment
  • Complete batch records, logbooks, and controlled forms accurately and in real time (GDP/ALCOA+ expectations)
  • Follow SOPs and safety procedures
  • escalate deviations, documentation errors, or abnormal events promptly
  • Participate in deviation investigations, CAPA actions, and change controls by providing clear documentation and input
  • Perform line clearance, room clearance, and cleaning/sanitization of compounding suites and classified areas
  • Assist with equipment cleaning/assembly, preventative maintenance support, and status labeling (e.g., mixers, balances, tanks, pumps)
  • Support calibration readiness and ensure equipment is within calibration and properly released for use
  • Support environmental monitoring activities (e.g., surface sampling, viable/non-viable particulates) and proper sample handling per procedure
  • Manage inventory of sterile compounding consumables and materials (labels, disinfectants, sterile components) and ensure proper storage/segregation
  • Verify raw material identity and status (quarantine/released) and maintain traceability for lot-controlled components
  • Adhere to chemical hygiene, biosafety, and aseptic safety expectations
  • use required PPE and safe handling practices
  • Contribute to continuous improvement initiatives (5S, waste reduction, right-first-time documentation, cycle time improvements)
  • Train on and maintain proficiency in aseptic technique, gowning qualification, and cleanroom behaviors

Requirements:

  • High School Diploma or GED required
  • 1+ year experience in one or more of the following: sterile compounding, aseptic manufacturing, cleanroom operations, pharmaceutical/biotech production, or regulated laboratory work
  • Ability to follow detailed written procedures and complete GMP documentation with strong attention to detail
  • Comfortable working in a cleanroom environment (gowning, gloving, disinfecting, controlled behaviors)
  • Basic math skills for weighing, solution preparation, and conversions
  • Ability to lift/push/pull up to 40 lbs and perform repetitive tasks while standing for extended periods

Nice to have:

  • Associate degree (or higher) in a scientific/technical field (Biology, Chemistry, Biotechnology, Pharmaceutical Technology, etc.)
  • Experience in sterile compounding, aseptic technique, and/or working in ISO-classified areas
  • Familiarity with cGMP expectations, GDP documentation practices, and regulated manufacturing environments
  • Experience with: Solution preparation (buffers/media)
  • Filtration concepts (sterile filtration setups)
  • Environmental monitoring support
  • SAP/ERP systems, electronic batch records (EBR), or LIMS

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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