Key Responsibilities
 Perform aseptic tissue processing of umbilical cord tissue per approved Standard
Operating Procedures (SOPs) and batch records.
 Process within an ISO 7 cleanroom using proper gowning, aseptic techniques, and
material handling practices.
 Perform tissue dissection, centrifugation, filtration, and other related processing
techniques under biosafety cabinet (ISO 5) conditions.
 Complete accurate, timely, and compliant batch production records and associated
documentation following ALCOA+ principles and Good Documentation Practices.
 Monitor and document environmental conditions, equipment parameters, and in-process
checks.
 Prepare, clean, and sanitize cleanroom equipment, materials, and workspaces as required.
 Assist with material staging, inventory control, and equipment setup/calibration.
 Participate in deviation investigations, CAPAs, and continuous improvement initiatives.
 Support validation and qualification activities for equipment, facilities, and processes.
 Adhere to all safety, environmental, and quality regulations, including 21 CFR Part 1271,
210/211, and internal quality systems.
Qualifications
Required:
 Associates or Bachelor’s degree in Biology, Biotechnology, Biomedical Science, or
related field, or equivalent industry experience.
 Minimum 1–3 years of experience in a regulated (GMP, ISO 13485, FDA) manufacturing
or tissue processing environment.
 Experience working in ISO 7 cleanroom environments and operating under aseptic
conditions.
 Strong understanding of cleanroom behavior, contamination control, and aseptic
technique.
 Excellent documentation practices and organizational skills.
Preferred:
 Experience with human tissue handling (e.g., umbilical cord, placenta, bone marrow).
 Familiarity with 21CFR 1271
Physical Requirements
 Ability to gown and work for extended periods in cleanroom environments.
 Manual dexterity to perform precise dissection and aseptic techniques.
 Ability to lift up to 25 lbs. and stand for long periods of time.
Job Type: Full-time
Pay: $60,000.00 - $70,000.00 per year

Benefits:

• Paid time off

Ability to Commute:

• Melville, NY 11747 (Required)

Ability to Relocate:

• Melville, NY 11747: Relocate before starting work (Required)

Work Location: In perso

Please refer the Job description for details