Production Associate I
Organogenesis
August 09, 2026
On-site
Canton, MA
Operations
What You Will Achieve:
The Production Associate performs aseptic processing of living products; production of ICL and FortaFlex Products; and/or supervised activities associated with HTP products, supporting Manufacturing with safe, timely processing in Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8 cleanrooms.
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) per Quality System regulations and established procedures (with supervision).
- Follow Operating Procedures, batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness/accuracy.
- Write deviation and corrective/preventative action reports as needed.
- Prepare media and sanitizing agents; rinse/segregate/inspect equipment; run glassware washers.
- Measure/cut tubing; prepare production set-ups; wrap equipment for sterilization and sterilize.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies (including bloodborne pathogen handling).
- Maintain supply inventory as directed; operate cleanroom equipment.
Qualifications/Skills:
- High school diploma or equivalent (required).
- Bachelor’s degree or biotech certificate; cGMP/quality systems and cleanroom experience (preferred).
- Aseptic technique and cleanroom protocol experience (desired).
- Knowledge of standard lab techniques/equipment (balances, pipettes, stir bars/bases, pH meters).
- Ability to work extended periods in cleanroom; dexterity/coordination; some lifting; work independently and in teams.
- Ability to lift up to 50 lbs.
Schedule: Sunday–Thursday or Monday–Friday, ~7:30am–4:00pm (or 6:30am–3:00pm; or 11:30am–8:00pm during some periods). Some weekend/holiday work.
Benefits (explicit): 401(k) w/ generous match and immediate vesting; comprehensive medical/dental/vision; education assistance ($5,000/yr); paid time off (vacation, holidays, sick time); wellness program; employee assistance program.
The Production Associate performs aseptic processing of living products; production of ICL and FortaFlex Products; and/or supervised activities associated with HTP products, supporting Manufacturing with safe, timely processing in Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8 cleanrooms.
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) per Quality System regulations and established procedures (with supervision).
- Follow Operating Procedures, batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness/accuracy.
- Write deviation and corrective/preventative action reports as needed.
- Prepare media and sanitizing agents; rinse/segregate/inspect equipment; run glassware washers.
- Measure/cut tubing; prepare production set-ups; wrap equipment for sterilization and sterilize.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies (including bloodborne pathogen handling).
- Maintain supply inventory as directed; operate cleanroom equipment.
Qualifications/Skills:
- High school diploma or equivalent (required).
- Bachelor’s degree or biotech certificate; cGMP/quality systems and cleanroom experience (preferred).
- Aseptic technique and cleanroom protocol experience (desired).
- Knowledge of standard lab techniques/equipment (balances, pipettes, stir bars/bases, pH meters).
- Ability to work extended periods in cleanroom; dexterity/coordination; some lifting; work independently and in teams.
- Ability to lift up to 50 lbs.
Schedule: Sunday–Thursday or Monday–Friday, ~7:30am–4:00pm (or 6:30am–3:00pm; or 11:30am–8:00pm during some periods). Some weekend/holiday work.
Benefits (explicit): 401(k) w/ generous match and immediate vesting; comprehensive medical/dental/vision; education assistance ($5,000/yr); paid time off (vacation, holidays, sick time); wellness program; employee assistance program.