Manufacturing Associate I/II

Job Responsibilities

• Maintain aseptic processing controls in a cleanroom environment.
• Document tasks in manufacturing records and logbooks following Good Documentation Practices (GDP).
• Maintain and perform maintenance on equipment according to Standard Operating Procedures (SOPs).
• Ensure materials are issued and accounted for during record execution.
• Demonstrate and apply knowledge of cGMP and its application to specific tasks.
• Participate in workplace organization (5S) activities.

Requirements

• Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
• Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent.

Qualifications

• Basic knowledge of upstream (cell culture or fermentation) unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated, and dynamic individual.

Skills

Knowledge of upstream (cell culture or fermentation) unit operations, single-use platform technology, MS Office, ERP, EDMS, production equipment software, and office equipment.

Benefits

N/A

Pay

N/A

Schedule

2-2-3 shift, Day Shift (7am-7pm)

Working Conditions

• Working 12-hour shifts which may include working overnight.
• Working within a cGMP manufacturing biotechnology facility which requires clean room operations.
• Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.
• Equipment and materials may include mechanical, chemical, electrical, and tripping/falling hazards.
• The noise level in the environment is moderate to high.