Associate Manufacturing- Manufacturing Services (Nights)

Role Summary

Associate Manufacturing - Manufacturing Services (Nights) performs operations on the night shift and provides technical leadership to the team under the Manufacturing Services manager. All operations are conducted in accordance with Standard Operating Procedures (SOPs).

Responsibilities

• Perform and monitor critical processes, complete routine validation protocols, and review documents such as Manufacturing Procedures and SOPs.
• Perform basic troubleshooting and assist in the review of documentation for assigned functions.
• Initiate and own area Deviations, revise SOPs, and perform LEAN functions.
• Work a 12-hour night shift (7 PM–7 AM) on a rotating schedule (C Shift), with a 15% shift differential and premium pay for Sundays.
• Onboarding period of 2–6 weeks will be administrative (Monday through Friday, approximately 8 AM–5 PM).

Qualifications

• Required: High school/GED + 2 years of manufacturing or operations work experience OR Associate’s + 6 months of manufacturing or operations work experience
• 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

Skills

• Technical writing capability with TrackWise access
• GMP knowledge and ability to interpret/apply GMP concepts
• Knowledge of MES and SAP systems
• Strong troubleshooting skills on Manufacturing Services equipment
• Ability to operate Power Industrial Vehicles

Education

• Bachelor’s degree