Role Summary
Associate Manufacturing Nights is a manufacturing operations role that performs and monitors critical processes in the Manufacturing area under general supervision, following SOPs. The position works a 12-hour night shift (7:00 PM–7:00 AM) on a rotating C Shift, with a 15% shift differential and Sunday premium pay. Onboarding may begin with administrative hours (Monday–Friday, 8:00 AM–5:00 PM) for 2–6 weeks. You will contribute to documentation, validation, troubleshooting, cross-functional collaboration, and continuous improvement to support the production of medicines.
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
- Preferred: CFR and Regulatory knowledge
- Preferred: Mechanical ability/expertise
- Preferred: Knowledge of lab equipment and computers
- 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
- Preferred: Able to demonstrate project management skills and presentation skills
- Preferred: Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Preferred: Basic troubleshooting skills
- Preferred: Experience with Delta V, RD’s
- Preferred: Experience with lab equipment/testing