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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