IGIV-C Technician I/II

1 month 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.



SHIFT: 12-hour Rotating

The IGIV-C Technician is responsible for the isolation of IgG by processing plasma intermediate paste and performing 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.

TECH I:
Primary Responsibilities:

• Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.


• Assists in the preparation of all solutions required for the process area and dispenses necessary cleaning/sanitization reagents to clean and sanitize production areas and equipment.

• Demonstrates the care and safety necessary to properly safeguard facilities, equipment, product and co-workers.

• Assembles and disassembles production equipment.

• Operates production equipment (i.e. filters, vessels, skids, columns, etc.).

• Operates fork truck in a safe and efficient manner.

• Operates CIP circuits.

• Monitors and controls processes utilizing the DCS.

• Performs real time documentation during production run and maintains accurate records/logs.

• Performs integrity tests on Sterile Filters.

Additional Responsibilities:

Buffer Prep Activities: Prepare filter aid for dispensing to zone 1, prepare and install filters, set up transfer panels and filters, assist in unloading of bulk chemical delivery tankers utilizing the DCS; initiate chemical loop circulation, monitor the state of solutions. Zone 1 Activities: Receive and stage II+III paste, calibrate tank pH probes, prepare equipment and harvest filter cake. Zone 2 Sterile Processing Activities: Prepare and test sterile filters, oscillate and sample sterile bulks, assist in the preparation of initial sterile bulks, deliver bulks and sterilize the bulk tank to sterile filter connection. Zone 2 Purification Processing Activities: Assist in the regenerate, testing and packing of columns, assist in cleaning and testing U/F systems, utilize DCS and Unicorn control systems, assist in formulation of sterile bulks, calibrate tank pH and conductivity probes, prepares and installs filters for use, sample and test process solutions.

Knowledge, Skills & Abilities:

Basic math skills, basic computer skills, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgment.

Requirements:

• High School diploma OR GED required

• One year of regulated industry (FDA, USDA, NRC) experience OR Graduation from an accredited college/university with an Associate's or Bachelor's degree OR Completion of the Bioworks Certification Program preferred

Education Requirements:

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.

TECH II:
Primary Responsibilities:

• Performs all duties described at IGIV-C Technician level.

• Performs GMP and Safety Audits of Process area.

• Prepares and operates production equipment to standards (i.e. filters, column, bulk tanks, etc.) .

• Troubleshoots and identifies problems with production processes and equipment.

Additional Responsibilities:

Buffer Prep: Prepare all buffer solutions and prepare and install filters, set up transfer panels for transfer to staging tanks, unload bulk chemical delivery tankers utilizing the DCS, sample and perform tests to determine acceptability of prepared solutions, initiate chemical loop circulation and monitor solutions. Zone 1: Stage and add II & III paste and calibrate tank pH probes. Zone 2 Sterile Processing: Prepare initial sterile bulks, oscillate, sample and sterilize bulks. Column Processing: Assist in loading, performing evaluation testing and packing IGIV-C chromatography column. UF/DF Processing: Clean and perform evaluation testing of system, monitor and control chromatography and UF/DF process, assist in initial sterile bulk formulation, sample and test solutions, calibrate tank pH and conductivity probes, prepare and install filters and install UF cassette in UF skid.

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 in a manner consistent with the requirements of applicable state and local laws.

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

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