Aseptic Filling Machine Operator (ISO 5)
Job Description
Job Description
About us
Samson Pharmaceuticals Inc. is an FDA-registered manufacturer of OTC eye drops, nasal sprays, cosmetics, and supplements. We operate ISO-classified cleanrooms (ISO 8 ’ 7 ’ 6 ’ 5) and follow strict cGMP and aseptic practices.
Compensation schedule
Multiple shifts are available, compensation, benefits is based on experience, shift time, both are negotiated
What you’ll do
• Start up and shut down an inline/monoblock eyedrop line (bottle feed fill, tip/inner plug insertion, cap place/torque).
• Perform line clearance pre-op checks (materials, torque/test tools, filter integrity status if applicable, utilities, sensors, interlocks).
• Set up bowls/chutes/escapements, nozzles, starwheels, rails, torque heads; execute format changeovers.
• Troubleshoot minor mechanical, pneumatic, and sensor/HMI issues to minimize downtime; escalate as needed.
• Execute in-process controls: fill-weight/volume checks, tip/cap presence torque checks, leak/visual inspection.
• Follow cGMP, GDP, and aseptic/ISO-5 gowning procedures; maintain housekeeping and support environmental monitoring activities (surface/air plates as directed by QA/QC).
• Complete batch records, logs, and line clearance forms accurately and on time; report deviations/OOS immediately.
• Collaborate with QA/QC/Maintenance to meet plan, quality, and safety targets.
Must-have qualifications
• 2+ years operating equipment inside ISO 5 (or equivalent aseptic environment) in pharma/OTC/medical device.
• Proven experience starting, setting up, and running a filling/capping line; strong mechanical aptitude.
• Knowledge of cGMP, Good Documentation Practices, and basic operation.
• Able to gown for ISO 5 (no makeup/jewelry; facial hair per policy), stand for long periods, and lift up to 40 lb.
• Strong attention to detail, basic math for line checks, and clear written/verbal communication.
• Work authorization in the U.S.; reliable commute to Commerce, CA.
Nice to have
• Ophthalmic (fill, tip + cap) experience; torque testing; leak testing.
• Filter integrity (bubble point) familiarity; autoclave/SIP/CIP basics.
• PLC basics, pneumatics, or mechatronics troubleshooting.
• Quality/Microbiology, EM coursework or experience.
• Experience with Odoo/MES/ERP data entry.
• Bilingual (English/Spanish).
Why join Samson
• Stable, growing LA manufacturer with modern cleanrooms.
• Hands-on role with real impact on quality and throughput.
• Ongoing training and advancement opportunities.
How to apply
Apply on Indeed with your resume. Please highlight specific machines you’ve run (e.g., ophthalmic fillers, tip/cap monoblocks, spindle/rotary cappers, vibratory bowl feeders) and your ISO-5 experience.
Screening questions
1) How many years have you worked inside ISO 5 or aseptic cleanrooms?
2) Describe a line you’ve started up and set up end-to-end (includefill, tip/cap steps).
3) What in-process checks did you perform (fill volume, torque, leak, vision, etc.)?
4) Are you able to gown for ISO-5 and comply with no-jewelry/no-makeup policies?
5) Are you comfortable lifting 40 lb and standing most of the shift?
6) Are you legally authorized to work in the U.S.?
7) What shifts are you available for, and can you work OT/weekends if needed?
8) (Optional) Experience with PLC basics/pneumatics? With Odoo/ERP?
EEO statement
Samson Pharmaceuticals Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.