Execute manufacturing processes including preparation, operation, and cleaning of production equipment under GMP conditions.Perform aseptic operations in cleanroom environments following strict gowning and contamination control procedures.Accurately complete batch records, logbooks, and other documentation in compliance with GDP (Good Documentation Practices).Prepare buffers, media, and reagents according to standard operating procedures (SOPs).Conduct in-process checks and monitor critical parameters during production runs.Clean, sanitize, and maintain manufacturing areas and equipment to ensure a sterile environment.Assist with equipment calibration, validation, and troubleshooting activities.Follow environmental health and safety regulations and report deviations or incidents promptly.Collaborate with cross-functional teams including QA, Engineering, and R&D to support continuous improvement initiatives.
4-7 years
Experience with upstream (e.g., cell culture, fermentation) or downstream (e.g., chromatography, filtration) manufacturing processes.Familiarity with single-use systems and automated control systems (e.g., DeltaV, SCADA).Understanding of Lean Manufacturing and/or Six Sigma methodologies.Prior involvement in equipment qualification or process validation.
High school diploma or GED required; associate or bachelor???s degree in Biotechnology, Biology, Chemistry, or related field preferred.Minimum 1???3 years of GMP-compliant manufacturing experience, preferably in the biotech or pharmaceutical industry.Knowledge of cleanroom operations and aseptic techniques.Ability to follow detailed written instructions and maintain accurate records.Basic computer proficiency (e.g., MS Word, Excel, electronic batch records).Strong attention to detail, organizational skills, and the ability to work both independently and in a team.
Bachelors
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