Fractionation Tech - NFF Details

Fractionation Tech - NFF

Grifols Therapeutics LLC - Clayton, NC

Employment Type : Full-Time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

SHIFT: 12-Hour, Night 7:00PM - 7:00AM

Summary:

The Fractionation Technician I is responsible for processing plasma to intermediate paste or dry powder stage, while maintaining a high level of housekeeping and conforming to highest standards of GMP and safety.

The Fractionation Technician II is responsible for processing plasma to intermediate paste or dry powder stage, while maintaining a high level of housekeeping and conforming to highest standards of GMP and safety.

The Fractionation Technician III is responsible for processing plasma to intermediate paste or dry powder stage, while maintaining a high level of housekeeping and conforming to highest standards of GMP and safety.

Primary responsibilities for role:

Fractionation Technician I

• Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.
• Demonstrates sound knowledge and understanding of GMP requirements.
• Dispenses and prepares necessary cleaning/sanitization reagents.
• Assembles, disassembles, cleans, and sanitizes production equipment and area.
• Operates production equipment (i.e. scales, conductivity meters, centrifuges, etc.)
• Prepares buffer and chemical solutions.
• Completes record keeping in accordance with CGMP.
• Demonstrates proper use of log books and works with and disposes of biohazardous waste.
• Samples processes as needed (i.e. deviations) and interprets process schedules.

Fractionation Technician II

• Performs all duties described at the Fractionation Operator level.
• Operates the acetone drying process utilizing the Funda Filter or works on the -5 production floor.
• Suspends Fraction V paste, Fraction II + III & Fraction II + IIIW paste of non-hyperimmune IM IG product lines.
• Assists in training less experienced employees.
• Demonstrates initiative in the performance of duties.
• Writes the process flow for pool plasma through Fraction II, PPF and albumin powder.

Fractionation Technician III

• Performs all duties described at the Fractionation Technician II level.
• Assists Coordinators with work assignments and fills in for Coordinators as needed.
• Fills in as Coordinator as needed.
• Demonstrates the ability to recognize unusual situations and notifies management when scheduling equipment, product yields or security are involved).
• Controls and monitors set point of process vessel.
• Controls and monitors temperatures.
• Acknowledge DCS alarms.
• Controls and monitors Alcohol and WFI batcher.
• Cooperates and works within Fractionation and with external departments to ensure success with departmental, process and/or equipment changes.
• Ability to troubleshoot situations in area of responsibility.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Additional responsibilities:

Fractionation Technician I

Minus 5 Processing: Prepares, sets up, operates, and performs bowl changes on Westfalia and Sharlpes centrifuges, suspends all intermediate fractions suspended in fractionation -5 C processing, performs filtration. Acetone Drying: Calculates and adds acetone and CWFI for processing, suspends Albumin and PFF paste for acetone, harvests and weighs acetone dried powder drying.

Fractionation Technician II

NA

Fractionation Technician III

Process all hyper immunes, IGIV products and reworks for optimum quality and yield, suspends final paste and freezes prior to freeze drying.

Education, Skills, and Abilities:

Fractionation Technician I

Candidate must possess a high school diploma or equivalent

Bioworks Certificate OR 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) OR a 2 or 4 year college degree is preferred but not required

Fractionation Technician II

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 OR 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) OR a 2 or 4 year college degree is preferred but not required

Fractionation Technician III

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 OR 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) OR a 2 or 4 year college degree is preferred but not required

Experience:

Fractionation Technician I

See Education

Fractionation Technician II

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

Fractionation Technician III

Requires 12 months as a Technician II and on target for a PMP rating of "Achieves Expectations" or 9 months as a Technician II and on target for a PMP rating of "Exceeds Expectations" level.

Equivalency:

Fractionation Technician I

NA

Fractionation Technician II

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.

Fractionation Technician III

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

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 and moving machinery. Exposure to high levels of noise and to occasional extreme cold below 20* in freezer. Occasional entry into confined spaces, requiring kneeling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves and hearing protection. Work is performed standing 6-8 hours a day. Frequently walks 6-8 hours per day, potential to walk on uneven surfaces. Frequently bends and twists waist and neck. Frequent hand movement for 6-8 hours per day 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. Frequently lifts above shoulder height. Frequently lifts and carries 15lbs, with occasional lifts and carrying objects up to 45 lbs. Maximum lift of 50lbs. 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 routine tasks by following a set of written or oral instructions/procedures. Maintains work pace to meet production standards.

EEO Females/Minorities/Disability/Veterans

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

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