Purification Technician I/II

Summary:

The Purification Technician performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace, cleaning, assembling and disassembling operating equipment per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.

Level I:

• Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.
• Demonstrates a sound knowledge and understanding of GMP requirements.
• Demonstrates the care and safety necessary to properly safeguard facilities, equipment, product and co-workers.
• Dispenses and prepares necessary cleaning/sanitization reagents to clean and sanitize production areas.
• Assembles, disassembles, cleans and sterilizes production equipment (i.e. filters, tanks, etc.).
• Operates production equipment (i.e. centrifuge, ultra filtration units, columns, autoclaves, pasteurizers, etc.).
• Operates fork truck in a safe and efficient manner.
• Performs bulk processing and filtration involving processing parameters (i.e. pH, weights, suspension, etc.).
• Performs real time documentation during production run and maintains accurate records/logs.
• Prepares buffer solutions and properly stores process intermediates.

Additional Responsabilities:

Isolate target proteins from intermediates and process to a sterile bulk and deliver for filling.

Level II:

• Performs all duties described at the Purification Operator level.
• Assembles, disassembles and operates production equipment (i.e. Spectrophotometer).
• Performs pH and buffer addition.
• Prepares samples.
• Performs calculations for processing.
• Weighs all powders, chemicals, and reagents needed and performs all calculations, preparations and reagent additions.
• Performs all routine operations associated with actual bulk preparation.
• Performs all pre and post filtration integrity tests.
• Performs bulk processing and filtration involving processing parameters (i.e. pH, weights, suspension, etc.).
• Recognizes and identifies mechanical and safety hazards to the proper individuals.

Requirements:

Level I:

Basic math skills, basic computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgment.
Candidate must possess a high school diploma or equivalent. Bioworks Certificate preferred.

Level II:

Typically requires a minimum of 12 months as a Technician in his/her respective department before receiving consideration for advancement to Purification Tech II. Employee must receive a minimum of a meets expectations overall rating on his/her most recent performance review.

Occupational Demands:

Must be able to lift up to 50 lbs, as well as stand/walk continuously during the shift, and work rotating shifts. Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Occasional entry into confined spaces requiring kneeling and squatting. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Work is performed standing and walking for 4-6 hours per day. Bending and twisting neck and waist for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement. Frequent moderate lifting and carrying of 15-44lbs. Frequent heavy lifting and carrying of 45lbs. with a maximum lift of 50lbs. Occasionally reaches above and below shoulder height. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures.