IGIV-C Technician I/II (E630)

GRIFOLS, S.A.•NC-Clayton, CA

12d•Onsite

About The Position

The IGIV-C Technician is responsible for isolating IgG by processing plasma intermediate paste and performing manufacturing tasks in a GMP environment. The role includes maintaining a clean workplace, cleaning and assembling or disassembling operating equipment according to applicable procedures, assisting with process-control activities, and maintaining records and logs in accordance with current standard procedures. The position works rotating 12-hour shifts, including days and nights, in a manufacturing environment. Technician I responsibilities include housekeeping; preparing process solutions and cleaning or sanitization reagents; safeguarding facilities, equipment, product, and coworkers; assembling, disassembling, and operating production equipment; operating a forklift, CIP circuits, and process controls through DCS; maintaining production records; and performing sterile-filter integrity tests. Additional duties vary across buffer preparation, Zone 1, sterile processing, and purification processing. Technician II performs all Technician I duties and additionally conducts GMP and safety audits, prepares and operates production equipment to standards, and troubleshoots production processes and equipment. Additional duties include buffer preparation and testing, Zone 1 paste staging and pH-probe calibration, sterile-bulk processing, chromatography-column work, and UF/DF system operation and testing. The position requires a high school diploma or GED. Advancement to Technician II typically requires at least 12 months as a technician in the respective department, a meets-expectations or higher rating on the most recent performance review, independent competence in at least one process area, and proficiency in at least two process areas. The role requires the ability to lift up to 50 pounds, stand and walk continuously during the shift, and work rotating shifts. Hepatitis B vaccination is required due to exposure to plasma fractions. Work involves exposure to biological fluids, potentially infectious organisms, chemicals, electrical equipment, moving machinery, noise, dust, gases, fumes, steam, and extreme cold. Occasional confined-space entry and work at heights are required, along with use of personal protective equipment.

Requirements

High school diploma or GED.
Basic math skills.
Basic computer skills.
Mechanical aptitude.
Attention to detail.
Ability to work in a team environment and exercise good judgment.
Ability to lift up to 50 pounds and stand or walk continuously during the shift.
Ability to work rotating shifts.
Hepatitis B vaccination is required due to exposure to plasma fractions.
For consideration for Technician II advancement, typically at least 12 months as a technician in the respective department, a meets-expectations or higher most recent performance rating, demonstrated independent competence in at least one process area, and proficiency in at least two process areas are required.

Responsibilities

Isolate IgG by processing plasma intermediate paste.
Perform housekeeping and maintain clean, sanitary production areas and equipment.
Prepare process solutions and dispense cleaning and sanitization reagents.
Assemble, disassemble, clean, and operate production equipment according to procedures and standards.
Safeguard facilities, equipment, product, and coworkers.
Operate a forklift, CIP circuits, and production process controls using DCS.
Perform real-time production documentation and maintain accurate records and logs.
Perform integrity tests on sterile filters.
Prepare filter aid, install filters, set up transfer panels, assist with chemical tanker unloading, initiate chemical circulation, and monitor solutions.
Receive and stage Zone 1 paste, calibrate tank pH probes, prepare equipment, and harvest filter cake.
Prepare and test sterile filters, oscillate and sample sterile bulks, assist with sterile-bulk preparation, and sterilize bulk-tank connections.
Assist with regeneration, testing, and packing of columns; clean and test U/F systems; operate DCS and Unicorn control systems; formulate sterile bulks; calibrate pH and conductivity probes; and sample and test process solutions.
Perform GMP and safety audits of the process area (Technician II).
Troubleshoot and identify problems with production processes and equipment (Technician II).
Prepare and test buffer solutions, set up transfers to staging tanks, and monitor chemical solutions (Technician II).
Stage and add Zone 1 paste and calibrate tank pH probes (Technician II).
Prepare, oscillate, sample, and sterilize initial sterile bulks (Technician II).
Assist with loading, evaluation testing, and packing of IGIV-C chromatography columns (Technician II).
Clean and evaluate UF/DF systems, monitor and control chromatography and UF/DF processes, install UF cassettes, and prepare, sample, and test solutions (Technician II).