Purification Technician I/II

Grifols•Clayton, NC

9d•Onsite

About The Position

The Purification Technician performs fundamental production tasks in a Good Manufacturing Practices (GMP) environment. The role includes maintaining a clean workplace; cleaning, assembling, and disassembling equipment according to applicable procedures; assisting with process-control manipulations; and maintaining records and logs according to current standard procedures. The position works rotating 12-hour shifts, either 6 a.m.–6 p.m. or 6 p.m.–6 a.m., in a manufacturing environment. At Level I, the technician performs housekeeping to pharmaceutical-operation standards, follows GMP requirements, and safeguards facilities, equipment, product, and coworkers. Duties include preparing cleaning and sanitization reagents; assembling, disassembling, cleaning, and sterilizing production equipment; operating production equipment and forklifts; performing bulk processing and filtration; documenting production runs; preparing buffer solutions; and properly storing process intermediates. The technician also isolates target proteins from intermediates, processes them to sterile bulk, and delivers them for filling. At Level II, the technician performs the duties described for the Purification Operator level, including assembling, disassembling, and operating production equipment; performing pH and buffer additions; preparing samples; completing processing calculations; weighing and preparing powders, chemicals, and reagents; performing routine bulk-preparation operations and pre- and post-filtration integrity tests; and identifying mechanical and safety hazards for the appropriate individuals. Work is performed in a manufacturing environment and involves exposure to biological fluids and potentially infectious organisms, chemicals, electrical manufacturing equipment, hand tools, moving machinery, high noise levels, and temperatures below 32°F. The position requires use of personal protective equipment and may involve occasional entry into confined spaces.

Requirements

Basic math skills.
Basic computer skills.
Mechanical aptitude.
Attention to detail.
Ability to work in a team environment and exercise good judgment.
High school diploma or equivalent for Level I.
Ability to lift up to 50 pounds and stand or walk during the shift.
Ability to work rotating shifts.
For Level II consideration, typically at least 12 months as a Technician in the respective department.
For Level II consideration, a minimum rating of “meets expectations” on the most recent performance review.
Ability to perform frequent hand and finger movements, precise coordinated movements, and frequent foot movements.
Ability to perform bending and twisting of the neck and waist, and occasional reaching above and below shoulder height.
Hearing acuity; color and depth perception; and far vision correctable to 20/30 in one eye and 20/100 in the other eye.
Ability to communicate and understand information presented through spoken and written words and sentences.
Ability to perform routine tasks by following written or oral instructions and procedures.
Ability to use required personal protective equipment, including protective eyewear, safety shoes, gloves, and garments.

Nice To Haves

Bioworks Certificate preferred.

Responsibilities

Maintain a clean workplace and perform housekeeping to pharmaceutical-operation standards.
Follow GMP requirements and safeguard facilities, equipment, product, and coworkers.
Prepare cleaning and sanitization reagents and clean and sanitize production areas.
Assemble, disassemble, clean, and sterilize production equipment.
Operate production equipment, including centrifuges, ultrafiltration units, columns, autoclaves, pasteurizers, and spectrophotometers.
Operate forklifts and other power equipment safely.
Perform bulk processing and filtration involving parameters such as pH, weights, and suspension.
Document production runs in real time and maintain accurate records and logs.
Prepare buffer solutions and properly store process intermediates.
Isolate target proteins from intermediates, process them to sterile bulk, and deliver them for filling.
At Level II, perform pH and buffer additions, prepare samples, and calculate processing requirements.
At Level II, weigh powders, chemicals, and reagents and perform their calculations, preparations, and additions.
At Level II, perform routine bulk-preparation operations and pre- and post-filtration integrity tests.
Recognize and report mechanical and safety hazards to the appropriate individuals.