Manufacturing Associate

• Job Title:     Manufacturing Associate
• Location:     Portsmouth, NH, 03801 
• Duration:     12 Months    Job Type:     
• Temporary Assignment
• Work Type: Onsite 
• Shift:            Night Shift from 07:00 PM to 07:00 AM (12 hours) - Rotating Shift

Job Summary

The Biotechnologist Associate / Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. This role involves executing process recipes, operating and monitoring manufacturing equipment, performing basic laboratory testing, maintaining facility and equipment cleanliness, and ensuring compliance with GMP and GDP requirements. The associate is expected to develop proficiency in aseptic techniques, follow standard operating procedures (SOPs), and support production activities in a cleanroom environment under close supervision.

Responsibilities 

• Manufacture therapeutic proteins (API) in accordance with cGMP requirements.
• Execute process recipes and follow established SOPs and batch records.
• Set up, operate, and monitor manufacturing equipment and production processes.
• Perform Clean-in-Place (CIP) and Steam-in-Place (SIP) operations.
• Complete production documentation in written and electronic systems following GMP and GDP standards.
• Review manufacturing documentation as required.
• Perform basic laboratory testing, including, pH monitoring, Conductivity measurements and Product sampling and testing
• Transfer and move raw materials, chemicals, and production materials within manufacturing areas.
• Conduct routine cleaning and sanitization of equipment and facilities.
• Support 6S and continuous workplace organization initiatives.
• Attain qualification for assigned manufacturing tasks and maintain training records.
• Demonstrate aseptic techniques while handling materials and products.
• Work in a gowning-required cleanroom environment.
• Attend shift handovers, team meetings, and project-related activities.
• Manage routine administrative tasks, including email communication.
• Perform other duties as assigned.

Required Skills

• High School Diploma or equivalent experience is required
• Recent graduates from Associates or Bachelors degree from Science related field will also be considered.
• Prior work experience in a cleanroom, laboratory, or another sterile setting is preferred. 
• Prior experience with Aseptic Techniques and gowning procedures is preferred. 
• Working experience in manufacturing; cGMP setting preferred. 
• Basic understanding of cGMP, GMP, and GDP requirements.
• Ability to follow SOPs, batch records, and manufacturing procedures accurately.
• Knowledge of biopharmaceutical or API manufacturing processes.
• Experience operating manufacturing equipment and production systems.
• Familiarity with CIP (Clean-in-Place) and SIP (Steam-in-Place) processes.
• Basic laboratory skills, including pH, conductivity, and sampling techniques.
• Understanding of aseptic processing and contamination control practices.
• Strong documentation and record-keeping skills.
• Ability to work effectively in a cleanroom environment and follow gowning procedures.
• Good communication and teamwork skills.
• Ability to manage multiple tasks and follow training requirements.
• Basic computer skills for electronic documentation and email communication.
• Attention to detail and commitment to quality and compliance.