Production Associate I

Role Summary

Production Associate I at Organogenesis, supporting aseptic processing, production of ICL and FortaFlex products, or HTP products in a cleanroom environment. Provides manufacturing support to ensure safe and timely processing of products in a Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8 cleanrooms. Schedule typically Sunday-Thursday (7:30am-4:00pm) or Monday-Friday, with some weekend/holiday work.

Responsibilities

• Manufacture cellular-based products according to Master Batch Records and Operating Procedures under aseptic conditions.
• Perform tasks related to HTP/collagen products (layer separation, cleaning, spreading, cutting, milling, packaging) with supervision in compliance with Quality Systems.
• Adhere to all Operating Procedures, Batch records, protocols, regulatory requirements, GMPs, and safety guidelines.
• Review batch records for completeness, accuracy, and protocol compliance.
• Prepare deviation and corrective/preventative action reports as needed.
• Prepare media and sanitizing agents for Production areas.
• Rinse, segregate equipment, inspect cleanliness, operate glassware washers, and prepare equipment.
• Measure and cut tubing, prepare Production set-ups per SOPs, wrap equipment for sterilization, and sterilize equipment.
• Operate depyrogenation ovens and autoclaves.
• Follow safety policies, including bloodborne pathogen handling.
• Maintain supply inventory per production schedule.
• Operate all clean room equipment properly.

Qualifications

• High school diploma or equivalent required.
• Bachelor‚Äôs degree or Biotech certificate; knowledge of cGMP and clean room experience preferred but not required.
• Pre-employment lift test and physical may be required for some Manufacturing positions.
• Aseptic Technique and cleanroom protocol experience desired.
• Knowledge of standard lab techniques and equipment (balances, pipettes, stir bases, pH meters, etc.).
• Ability to work in a cleanroom environment for extended periods.
• Dexterity, coordination, and some lifting required.
• Ability to work independently and as part of a team.

Skills

• Cleanroom operations
• Aseptic processing
• GMP compliance
• Batch record review
• Equipment operation and sterilization techniques

Education

• High school diploma or equivalent required; degree/certificate in biotech or related field preferred.

Additional Requirements

• Physical ability to lift up to 50 pounds and perform tasks in a manufacturing environment.
• Ability to work in a cleanroom environment for extended periods; standing or sitting for prolonged periods.