Sterile Compounding Laboratory Technician

Sterile Compounding Laboratory Technician

Location: Lexington, KY (On-site)
Department: Manufacturing / Sterile Operations / Compounding
Reports to: Sterile Compounding Supervisor / Manufacturing Manager
Position Type: Full-Time

Position Summary

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.

Key Responsibilities

Sterile Compounding & Aseptic Operations

• 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.

Documentation & Compliance (cGMP)

• 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.

Cleanroom & Equipment Support

• 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.

Environmental Monitoring & Material Control

• 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.

Safety & Continuous Improvement

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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

Competencies

• Strong attention to detail and “right-first-time” mindset
• Reliable, punctual, and able to work independently or as part of a team
• Clear communication and willingness to escalate issues quickly
• Ability to learn and apply technical procedures in a regulated environment
• Commitment to safety, quality, and compliance

Work Environment & Physical Requirements

• Work performed in classified cleanrooms requiring gowning (coveralls, hood, mask, sterile gloves, goggles/face shield as required).
• Exposure to disinfectants and cleaning agents; handling of sterile components and lab/production materials.
• Standing/walking for extended periods; repetitive motions and fine motor tasks (assembling, labeling, weighing).