Associate Manufacturing-Nights

Role Summary

Associate Manufacturing - Nights. Perform operations in the Manufacturing area (Inoculation/Seeds) according to Standard Operating Procedures (SOPs). Work a 12-hour night shift (7PM–7AM) on a rotating schedule, with onboarding initially administrative (Mon–Fri, approx. 8AM–5PM).

Responsibilities

• Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
• Perform basic troubleshooting and assist in the review of documentation for assigned functions.
• Participate on cross-functional teams and represent the Inoc/Seeds group.
• May be responsible for NC/CAPA’s and Change Control records.
• Identify, recommend, and implement improvements related to routine functions.

Qualifications

• Required: High school/GED + 2 years of manufacturing or operations work experience OR
• Required: Associate’s + 6 months of manufacturing or operations work experience OR
• Required: Bachelor’s degree
• Preferred: Knowledge of small-scale bioreactors, wave bioreactors, and aseptic processing.
• Preferred: CFR and Regulatory knowledge
• Preferred: Mechanical ability/expertise
• Preferred: Knowledge of WIP lab equipment and computers, with LIMS access
• Preferred: Basic statistical mathematical skills
• Preferred: Ability to interpret and apply GMP knowledge
• Preferred: Understanding of analytical methods for manufacturing area
• Preferred: Ability to demonstrate technical writing capability with Trackwise access
• Preferred: Able to demonstrate project management skills and presentation skills
• Preferred: Independently collaborate with outside resources
• Preferred: Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Preferred: Basic troubleshooting skills on bioreactors
• Preferred: Experience with Delta V, RD’s
• Preferred: Experience with lab equipment/testing

Education

• High school/GED
• Associate’s degree
• Bachelor’s degree