Manufacturing Technician

Harba; Woburn (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

Harba is seeking an operations professional to perform manufacturing in an ISO Class 7 cleanroom, adhering to SOPs and cGMPs. The role includes aseptic cell culture manipulations, handling biological materials, and documenting activities in batch records.

The candidate will ensure equipment readings are within specifications, participate in quality-compliant documentation, and collaborate with QA/QC, Engineering and other teams. Strong attention to detail and teamwork are essential.

Qualifications

• High school diploma/GED with 2+ years of cGMP experience, or a Bachelor’s degree, preferably in a Life Science or related field.
• Experience in biopharmaceutical, pharmaceutical, cell therapy, biotech manufacturing, or laboratory operations is preferred.
• Experience in GMP/cGMP environments is preferred.
• Experience in ISO Class 7 cleanrooms is preferred.
• Familiarity with aseptic processing and controlled manufacturing environments is preferred.
• Strong attention to detail and ability to perform repetitive tasks accurately.
• Strong written and verbal communication skills.
• Ability to follow SOPs, batch records, safety procedures, and regulatory requirements.
• Basic proficiency with Microsoft Office and Excel.
• Ability to work independently and as part of a team.

Responsibilities

• Perform manufacturing procedures in an ISO Class 7 cleanroom per SOPs, cGMPs and safety rules.
• Aseptic manipulations of cell culture lots and final product assemblies.
• Handle biological materials with appropriate storage temperatures and integrity.
• Execute manufacturing processes accurately per procedures.
• Document activities in Electronic Batch Records and log sheets.
• Review production records for accuracy and cGMP compliance.
• Enter production data into electronic databases and inventory systems.
• Perform cleanroom housekeeping and sanitize equipment and areas.
• Record equipment readings and monitor operation against specs.
• Receive, label, inventory, store and prepare biological materials and supplies.
• Maintain inventory records, chain of custody and audit trails.
• Safely handle biological materials, chemicals, drug products, dry ice, and LN2 with PPE.
• Follow GMP, GTP, GLP, GDP, ISO and safety requirements.
• Collaborate with QA, QC, Engineering, Facilities, Materials, R&D, Training and Validation teams.
• Communicate effectively with cross-functional teams.
• Maintain a clean, organized, and compliant manufacturing environment.
• Perform other duties as assigned.

Skills

Attention to detail

Written and verbal communication

Team collaboration

Education

Bachelor's degree Life Sciences

High school diploma/GED with cGMP experience

Tools

Microsoft Office

Excel

Job description

Key Responsibilities

• Perform manufacturing procedures within an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs, and safety regulations.
• Perform aseptic manipulations of cell culture lots and final product assemblies.
• Handle biological materials while maintaining required storage temperatures and material integrity.
• Execute manufacturing processes accurately and consistently according to established procedures.
• Document manufacturing activities in Electronic Batch Records, log sheets, and other controlled documentation.
• Review completed production records for accuracy, completeness, and cGMP compliance.
• Enter production and material information into electronic databases and inventory management systems.
• Perform cleanroom housekeeping and sanitize manufacturing equipment and controlled areas.
• Record equipment readings and monitor equipment to ensure operation within established specifications.
• Receive, label, inventory, store, and prepare biological materials and manufacturing supplies.
• Maintain accurate inventory records, chain of custody, and audit trails.
• Safely handle biological materials, chemicals, drug products, dry ice, and liquid nitrogen using appropriate PPE and procedures.
• Follow applicable GMP, GTP, GLP, GDP, ISO, and safety requirements.
• Work collaboratively with QA, QC, Engineering, Facilities, Materials Management, R&D, Training, and Validation teams.
• Communicate effectively with cross-functional teams to support manufacturing activities.
• Maintain a clean, organized, and compliant manufacturing environment.
• Perform other duties as assigned.

Qualifications

• High school diploma/GED with 2+ years of cGMP experience, or a Bachelor’s degree, preferably in a Life Science or related field.
• Previous experience in biopharmaceutical, pharmaceutical, cell therapy, biotech manufacturing, or laboratory operations preferred.
• Experience working in a GMP/cGMP environment preferred.
• Experience working in an ISO Class 7 cleanroom preferred.
• Familiarity with aseptic processing and controlled manufacturing environments preferred.
• Strong attention to detail and ability to perform repetitive tasks accurately.
• Strong written and verbal communication skills.
• Ability to follow SOPs, batch records, safety procedures, and regulatory requirements.
• Basic proficiency with Microsoft Office and Excel.
• Ability to work independently and effectively within a team environment.

Physical & Working Requirements

• Ability to lift, carry, push, and pull up to 50 lbs.
• Ability to sit or stand for extended periods.
• Ability to bend, reach, and perform repetitive hand and finger movements.
• Ability to gown and gain entry to controlled manufacturing areas.
• Ability to work with dry ice and liquid nitrogen (LN₂) using appropriate PPE and techniques.
• Ability to work one weekend day per week and participate in rotating holiday coverage as required.
• May work in areas containing potentially infectious biological materials and must follow applicable safety procedures and Universal Precautions.