Biotech Manufacturing Associate – Cleanroom Operations

Spectraforce Technologies; Summit (NJ); On-site; USD 42,000 - 66,000; Full time

Job summary

Spectraforce Technologies is seeking a Manufacturing Associate for a 6‑month assignment in Summit, NJ. The role operates in a cGMP cleanroom environment under Manufacturing Management, with a production shift schedule that includes early hours and alternating Wednesdays.

Candidates should have a science background, be comfortable with data entry and SOPs, and participate in deviation investigations and CAPA closures as part of a team.

Qualifications

• Bachelor’s degree in a science field or equivalent
• Associates/Medical Tech degree with 3+ years in Manufacturing/Operations
• High School diploma with 2+ years in Manufacturing/Operations

Responsibilities

• Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write-ups as needed. Support close of any assigned CAPAs within the shift.
• Aseptic technique required for tube work: welding, connections, and transfers, at minimum. Aseptic qualification required.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time internal production logistics.
• Record production data and information in a clear, concise format according to GDPs.
• Perform tasks in line with site safety policies, quality systems, and GMP requirements.
• Work in a team-based, cross-functional environment to complete production tasks as per shift schedule.
• Motivated, team-conscious individuals are needed to fulfill job requirements.
• Become a SME and qualified trainer within a designated manufacturing function; supervision by shift supervisor or team lead.
• Maintain on-time completion of training assignments to maintain technical skills.
• Perform other tasks: continuous improvement projects, inspection readiness, right-first-time initiatives, etc.

Skills

Cell culture

Cryopreservation

Aseptic processing

Mathematics

cGMPs

Technical writing

MS Office

Biology background

Education

Bachelor's degree

Associate/Medical Technical degree

High School diploma/GED

Job description

Spectraforce Technologies is seeking a Manufacturing Associate for a 6‑month assignment in Summit, NJ. The role operates in a cGMP cleanroom environment under Manufacturing Management, with a production shift schedule that includes early hours and alternating Wednesdays.

Candidates should have a science background, be comfortable with data entry and SOPs, and participate in deviation investigations and CAPA closures as part of a team.