Production Associate I
Organogenesis
August 31, 2026
On-site
Canton, MA
Operations
What You Will Achieve:
The Production Associate performs activities in aseptic processing of living products, production of ICL and FortaFlex Products, or activities associated with HTP Product under the Manager’s supervision. Supports the Manufacturing Team to ensure safe and timely processing in Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8 cleanrooms.
Schedule:
- Sunday–Thursday or Monday–Friday, approx. 7:30am–4:00pm (some weekends/holidays)
- Sunday–Thursday or Monday–Friday, approx. 6:30am–3:00pm (some weekends/holidays)
- Sunday–Thursday or Monday–Friday, approx. 11:30am–8:00pm (some holidays); training up to 6 months, Monday–Friday 7:30am–4:00pm
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 procedures and Quality Systems regulations.
- 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 equipment; inspect cleanliness; run glassware washers.
- Measure/cut tubing; prepare production set-ups; wrap/sterilize equipment; run depyrogenation ovens and autoclaves.
- Follow safety policies (incl. bloodborne pathogen handling); maintain supply inventory; operate cleanroom equipment.
Qualifications:
- High school diploma or equivalent required.
- Bachelor’s degree or biotech certificate; cGMP knowledge and cleanroom experience preferred (not required).
- Pre-employment lift test/physical may be required for some manufacturing positions.
Skills/Abilities:
- Aseptic technique and cleanroom protocol experience desired.
- Knowledge of standard lab techniques/equipment (e.g., balances, pipettes, stir plates, pH meters).
- Ability to work independently and in a team; ability to work in cleanroom for extended periods.
- Dexterity/coordination and some lifting; ability to lift up to 50 lbs.
Benefits:
- 401(k) with employer match (immediate vesting).
- Medical, dental, and vision effective day one.
- Flexible Spending Account or Health Savings Account.
- Company-paid Short Term/Long Term/Life insurance.
- Education assistance ($5,000/year).
- Paid vacation/holidays/sick time; plus paid maternity/parental leave and adoption benefits.
- Employee Assistance Program; wellness program.
- Free parking (with electric charging station at Canton and La Jolla).
The Production Associate performs activities in aseptic processing of living products, production of ICL and FortaFlex Products, or activities associated with HTP Product under the Manager’s supervision. Supports the Manufacturing Team to ensure safe and timely processing in Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8 cleanrooms.
Schedule:
- Sunday–Thursday or Monday–Friday, approx. 7:30am–4:00pm (some weekends/holidays)
- Sunday–Thursday or Monday–Friday, approx. 6:30am–3:00pm (some weekends/holidays)
- Sunday–Thursday or Monday–Friday, approx. 11:30am–8:00pm (some holidays); training up to 6 months, Monday–Friday 7:30am–4:00pm
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 procedures and Quality Systems regulations.
- 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 equipment; inspect cleanliness; run glassware washers.
- Measure/cut tubing; prepare production set-ups; wrap/sterilize equipment; run depyrogenation ovens and autoclaves.
- Follow safety policies (incl. bloodborne pathogen handling); maintain supply inventory; operate cleanroom equipment.
Qualifications:
- High school diploma or equivalent required.
- Bachelor’s degree or biotech certificate; cGMP knowledge and cleanroom experience preferred (not required).
- Pre-employment lift test/physical may be required for some manufacturing positions.
Skills/Abilities:
- Aseptic technique and cleanroom protocol experience desired.
- Knowledge of standard lab techniques/equipment (e.g., balances, pipettes, stir plates, pH meters).
- Ability to work independently and in a team; ability to work in cleanroom for extended periods.
- Dexterity/coordination and some lifting; ability to lift up to 50 lbs.
Benefits:
- 401(k) with employer match (immediate vesting).
- Medical, dental, and vision effective day one.
- Flexible Spending Account or Health Savings Account.
- Company-paid Short Term/Long Term/Life insurance.
- Education assistance ($5,000/year).
- Paid vacation/holidays/sick time; plus paid maternity/parental leave and adoption benefits.
- Employee Assistance Program; wellness program.
- Free parking (with electric charging station at Canton and La Jolla).