Senior Aseptic Technician

Title: Aseptic Technician - IILocation: Pearl River, NYDuration: 9 months (Temporary/contract-to-permanent potential)Work Environment & ScheduleOn-site, 5 days per weekStandard hours: ~8:30 AM – 4:30/5:00 PM (non-batching periods)During production cycles:Early starts (~7:00 AM)Second shift shifts (up to midnight)Frequent schedule adjustments (~20 times/year)Occasional weekend work when needed (e.g., batch issues)Training duration: extensive (can take 6 months to 2+ years to fully ramp)Roles require long-term commitment due to complexityCandidates should be aligned with expectations and not seeking short-term exposure onlyKey Responsibilities:Execute downstream operations including:Sterile filtrationAseptic filling in isolatorsLyophilization (freeze-drying)Vial sealing and final processingPerform visual inspection of vials for: Glass defects, Product defects, Container integritySupport buffer preparation activities as neededOperate and monitor isolator and aseptic equipmentEnsure strict adherence to safety and sterility standardsContribute to: Documentation and reportingProcess optimizationTroubleshooting of manufacturing issuesCollaborate with upstream teams to continue production flowRequires use of advanced PPE (including full cleanroom/isolator suits)Required QualificationsBachelor’s degree preferred in: Biology, Chemistry, Engineering, or related field (Equivalent experience may be considered)Ability to follow complex procedures and work in sterile environmentsPreferred QualificationsExperience with:Aseptic techniquesCleanroom environmentsPharmaceutical manufacturingStrong time management and attention to detailIdeal Candidate ProfileEntry-level or early-career professionalDetail-oriented with strong procedural disciplineAble to work in highly controlled environmentsComfortable with schedule variability and hands-on productionStrong communication and documentation skillsDescription:The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques.A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control.Job Responsibilities: Perform aseptic gowning and operate in cleanroom environments.Prepare, sterilize, and transfer materials and equipment into cleanrooms.Execute aseptic filling, compounding, and packaging processes.Monitor environmental conditions and report deviations or contamination risks.Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).Maintain accurate batch records and documentation.Participate in cleaning, sanitization, and routine maintenance of cleanroom areas.Support quality assurance and validation activitiesSkills:Knowledge of aseptic techniques and cleanroom protocols.Strong attention to detail and adherence to procedures.Ability to work in a sterile, regulated environment for extended periods.Familiarity with GMP, FDA, and other regulatory requirements.Good communication and teamwork skills.Basic computer and documentation skills.Education/Experience:High school diploma or GED required; associate degree or technical training in life sciences preferred 2-4 years of experience in aseptic processing, pharmaceutical manufacturing, or a related field