Duties and Responsibilities 

• Key areas of responsibility include but not limited to preparation of buffer and media, weigh and dispense, operating the glass washer and autoclave, and supporting manufacturing teams as needed. 

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical material or validation activities). 

• Operate manufacturing process equipment to perform various manufacturing production steps. 

• Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines. 

• Order, receive and distribute supplies into production area as needed. 

• May perform other duties as assigned. (During Production Processing these activities may increase) 

• Knowledge of laboratory and pharmaceutical production equipment included but not limited to autoclaves, glass washer, process tanks, and analytical equipment. 

• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.) 

• Possess good knowledge of cGMP and cleanroom behavior  

• Such additional responsibilities as the Company may also assign. 

Qualifications 

• With high school diploma: 1 years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred. 

• Good with Microsoft Office – Outlook, Word, Excel. 

• Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time. 

• Able to read and follow detailed written instructions and have good verbal/written communication skills. 

• Able to write legibly and grammatically correct entries on records. 

• Good interpersonal skills and be able to work effectively and efficiently in a team environment. 

• Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule 

Working Conditions 

• Personal Protective Equipment must be worn as required 

• May require lifting amounts of 25 lbs. 

• Manufacturing operations tasks requires operator to regularly remain on feet for shift. 

• Pushing buffer containers ranging from 50L to 200L. 

• Sitting for periods of 2 to 3 hours. 

• Ability to work in a clean room environment and comply with hygiene standards and use of special garments. Additionally, personal protective equipment must be worn due to safety requirements. 

Physical Requirements 

• PPE as required. 

• May require lifting amounts of 25 lbs. 

• Manufacturing operations tasks requires operator to regularly remain on feet for shift.