Role Summary
Associate Manufacturing Nights will perform manufacturing operations under general supervision, following Standard Operating Procedures (SOPs). The role requires a 12-hour night shift (7PM-7AM) on a rotating schedule, with onboarding primarily administrative (mon-fri, 8am-5pm) for 2–6 weeks.
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 OR Associate’s + 6 months of manufacturing or operations work experience OR Bachelor’s degree
- Preferred: Knowledge of single-use Bio-manufacturing technology; CFR and Regulatory knowledge; Mechanical ability/expertise; Knowledge of lab equipment and computers; Basic statistical mathematical skills; Ability to interpret and apply GMP knowledge; Understanding of analytical methods for manufacturing area; Ability to demonstrate technical writing capability; Project management and presentation skills; Understanding and applying basic chemistry, biology and physical principles; Basic troubleshooting skills; Experience with Delta V, RD’s; Experience with lab equipment/testing
Education
- Bachelor’s degree (preferred or required as indicated)