Purification Technician I/II/III

3 weeks ago

Clayton, North Carolina, United States GRIFOLS, S.A. Full time


Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.



Hiring Manager: Jonathan Warren

SHIFT: 12 Hour Rotating; M-Th Days / M-W Nights

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.

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.

Level III:

  • Performs all duties described at the Purification Technician II level.
  • Demonstrates thorough knowledge, understanding and application of GMP and housekeeping requirements.
  • Independently operates production equipment.
  • Demonstrates the ability to trouble-shoot, identify and analyze unusual situations and recommend appropriate action for safety and product integrity.
  • Demonstrates considerable initiative in job performance so that close supervision is not necessary.
  • Cooperates and works with those in other departments as well as those in the immediate area to aid in a constructive approach toward departmental problems and process or equipment changes as instructed by supervisor.
  • Processes products through final sterile bulk stage (i.e. dilution, dispensing and proper sampling).
  • Assists in training less experienced operators in production, GMP and housekeeping.
  • 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.

Requirements:

Level I:

High school diploma or equivalent required. Candidate must possess a high school diploma or equivalent plus Bioworks Certificate or a high school diploma plus 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) within the past 5 years or a 2 or 4 year college degree.

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.

Level III:

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

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.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

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