Production Associate I
Organogenesis
June 26, 2026
On-site
Canton, MA
Operations
What You Will Achieve
Production Associate supporting Manufacturing in aseptic processing (living product), production of ICL and FortaFlex products, or HTP product activities under direct supervision. Works in cleanrooms (Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8).
Responsibilities
- Manufacture cellular-based products per Master Batch Records and Operating Procedures under aseptic conditions.
- Perform HTP/collagen tasks (layer separation, cleaning, spreading, cutting, milling, packaging) with supervision and in compliance with Quality Systems/GMPs.
- Follow Operating Procedures, batch records, protocols, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness/accuracy.
- Write deviation and corrective/preventive action reports as needed.
- Prepare media and sanitizing agents; rinse/segregate equipment; inspect cleanliness; run glassware washers and prepare equipment.
- Measure/cut tubing; set up production per SOP; wrap equipment for sterilization; sterilize equipment.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies (including bloodborne pathogen handling); maintain supply inventory; operate cleanroom equipment.
Qualifications
- High school diploma or equivalent (required).
- Bachelor’s degree or biotech certificate; cGMP/quality systems knowledge; cleanroom experience (preferred).
- Aseptic technique/cleanroom protocol experience (desired).
- Knowledge of standard lab techniques/equipment (balances, pipettes, stir bars, pH meters).
- Ability to work independently and in a team; work in cleanroom for extended periods.
- Dexterity/coordination; some lifting.
Required Skills/Physical
- Lift up to 50 lbs; prolonged standing/sitting; repeating hand/wrist motions; medium work moving objects up to 50 lbs.
What can we offer you (selected)
- 401(k) with immediate vesting and match.
- Medical/Dental/Vision effective day one.
- Flexible Spending Account or HSA.
- Education assistance ($5,000/year).
- Paid time off and paid holidays.
- Wellness/EAP/free parking (with electric charging).
Schedule
- Sunday–Thursday or Monday–Friday (various shifts noted); some weekend/holiday work required; training may run up to six months (Mon–Fri 7:30am–4:00pm).
Production Associate supporting Manufacturing in aseptic processing (living product), production of ICL and FortaFlex products, or HTP product activities under direct supervision. Works in cleanrooms (Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8).
Responsibilities
- Manufacture cellular-based products per Master Batch Records and Operating Procedures under aseptic conditions.
- Perform HTP/collagen tasks (layer separation, cleaning, spreading, cutting, milling, packaging) with supervision and in compliance with Quality Systems/GMPs.
- Follow Operating Procedures, batch records, protocols, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness/accuracy.
- Write deviation and corrective/preventive action reports as needed.
- Prepare media and sanitizing agents; rinse/segregate equipment; inspect cleanliness; run glassware washers and prepare equipment.
- Measure/cut tubing; set up production per SOP; wrap equipment for sterilization; sterilize equipment.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies (including bloodborne pathogen handling); maintain supply inventory; operate cleanroom equipment.
Qualifications
- High school diploma or equivalent (required).
- Bachelor’s degree or biotech certificate; cGMP/quality systems knowledge; cleanroom experience (preferred).
- Aseptic technique/cleanroom protocol experience (desired).
- Knowledge of standard lab techniques/equipment (balances, pipettes, stir bars, pH meters).
- Ability to work independently and in a team; work in cleanroom for extended periods.
- Dexterity/coordination; some lifting.
Required Skills/Physical
- Lift up to 50 lbs; prolonged standing/sitting; repeating hand/wrist motions; medium work moving objects up to 50 lbs.
What can we offer you (selected)
- 401(k) with immediate vesting and match.
- Medical/Dental/Vision effective day one.
- Flexible Spending Account or HSA.
- Education assistance ($5,000/year).
- Paid time off and paid holidays.
- Wellness/EAP/free parking (with electric charging).
Schedule
- Sunday–Thursday or Monday–Friday (various shifts noted); some weekend/holiday work required; training may run up to six months (Mon–Fri 7:30am–4:00pm).