Associate Mfg

Associate Mfg

Under minimal supervision, an Associate, Mfg, depending on experience, will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, primarily operation of automated fill equipment inside the aseptic environment. Candidates should understand basic computer skills, have GMP knowledge, good cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures.
Major duties will include:
• Operation of the fill/stoppering equipment to dispense sterile product into glass containers
• Environmental monitoring of the aseptic environment during each fill and after each fill
• Loading and unloading of sterile products from freeze dryers
• Operation of the continuous particulate monitoring system during each fill
• Assembling and disassembling of equipment before and after use
• Performing operations during fills by following proper procedures
Responsibilities also include:
• High levels of mechanical aptitude during setup and troubleshooting of the equipment. Trouble-shooting may include mechanical adjustments to the fill line.
• High levels of housekeeping to conform to cGMP standards
• Cleaning and sanitizing aseptic filling areas to maintain the quality of the product
• Detailed and accurate documentation in batch production records.

Basic Qualifications
• Bachelor's degree
OR
• Associate's degree & 4 years of directly related experience
OR
• High school diploma / GED & 6 years of directly related experience

Preferred Qualifications
Bachelors Degree in Mechanical Engineering, Technology and 3 plus years related experience preferred.
• Must be able to determine availability of components and assign accordingly.
• May also be required to assist in training of co-workers.
• Must be able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.
• Exposure to manufacturing equipment and moving machinery.
• Exposure to high levels of noise.
• Personal protective equipment required such as; protective eyewear, coverall gowning suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator.
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects.
• Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height.
• Color perception/discrimination, far vision correctable.
• Good oral and written communication skills
• Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures.