Associate Manufacturing - Day Shift

Role Summary

Manufacturing Associate I supporting the AR30 Downstream Purification line on Day Shift. Responsibilities include operating equipment, maintaining production records, and adhering to safety and quality standards to contribute to manufacturing efficiency. Onboarding lasts 2–6 weeks with an initial Monday–Friday schedule, then a 12-hour rotating shift (7am–7pm) with a two-week rotation and weekend considerations.

Responsibilities

• Under general supervision, perform operations in the manufacturing area.
• Operate according to Standard Operating Procedures (SOPs).
• Perform and monitor critical processes, complete routine validation protocols, and draft/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 manufacturing teams.
• Possess responsibility for deviations/CAPAs.
• Identify, recommend, and implement improvements related to routine functions.

Qualifications

• Required: High school/GED + 2 years of manufacturing or operations experience OR Associate’s + 6 months of manufacturing or operations experience OR Bachelor’s Degree in a related field
• Preferred: Bachelor’s degree in Science or Engineering; knowledge of large-scale biotechnology operations (purification, Protein A chromatography, VI/Neut, Tangential Flow Filtration); knowledge of Single-use Systems; CFR and regulatory knowledge; mechanical ability/expertise; basic statistical math skills; GMP knowledge; understanding of analytical methods for manufacturing; technical writing capability; project management and presentation skills; knowledge of chemistry, biology, and physical principles; basic troubleshooting on production equipment; experience with DeltaV; experience with lab equipment/testing

Skills

• Technical writing capability
• Project management and presentation skills
• Analytical method understanding for manufacturing
• Basic troubleshooting on production equipment

Education

• High school/GED with additional manufacturing experience or degree, or Associate’s/Bachelor’s as specified in Qualifications