Manufacturing Associate (Nights)

Role Summary

Manufacturing Associate (Nights) performs manufacturing operations under general supervision, following Standard Operating Procedures. The role involves a 12-hour night shift (7:00 PM–7:00 AM) on a rotating C shift, with added benefits including a 15% shift differential and premium pay for Sundays. Onboarding during the initial 2–6 weeks is administrative (Monday–Friday, approximately 8:00 AM–5:00 PM).

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 Manufacturing.
• May also have the responsibility of owning NC/CAPA’s.
• May identify, recommend, and implement improvements related to routine functions.

Qualifications

• Required: High school/GED + 2 years of manufacturing or operations work experience
• Required: Associate’s + 6 months of manufacturing or operations work experience
• Required: Bachelor’s degree
• Preferred: Knowledge of Washers and Autoclaves
• Preferred: Prior experience with process equipment, computers, and intermediate mathematical skills
• Preferred: Knowledge of LIMS and access
• Preferred: CFR and Regulatory knowledge
• Preferred: Mechanical ability/expertise
• Preferred: Experience and Knowledge of Weigh Dispensing
• Preferred: Strong understanding of BDS equipment and CIP and SIP processes
• Preferred: Basic statistical mathematical skills
• Preferred: Ability to interpret and apply GMP knowledge
• Preferred: Understanding of analytical methods for the manufacturing area
• Preferred: Ability to demonstrate technical writing capability with TrackWise access
• Preferred: Knowledge of MES and SAP systems
• Preferred: Independently collaborate with outside resources
• Preferred: Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Preferred: Strong troubleshooting skills on Manufacturing Services equipment
• Preferred: Ability to use Power Industrial Vehicles
• Preferred: Experience with Delta V, RDs, and the PI system
• Preferred: Demonstrated ability to lead teams