IGIV-C Technician I/II (PFF)

GRIFOLS, S.A.•NC-Clayton, CA

12d•Onsite

About The Position

The IGIV-C Technician isolates IgG by processing plasma intermediate paste and performs fundamental tasks in a GMP environment. Duties include cleaning and maintaining the workplace; cleaning, assembling, and disassembling operating equipment according to applicable procedures; assisting with process-control manipulations; and maintaining records and logs in accordance with current standard procedures. The position works rotating 12-hour shifts in a manufacturing environment. Technician II performs all Technician I duties and additional process-area responsibilities.

Requirements

High school diploma or GED.
Basic math and computer skills.
Mechanical aptitude and attention to detail.
Ability to work in a team environment and exercise good judgment.
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.
For consideration for advancement to Technician II: typically at least 12 months as a Technician in the respective department; a meets-expectations-or-higher rating on the most recent performance review; demonstrated independent competence in at least one listed process area; and proficiency in at least two listed process areas.
Ability to perform physical duties including frequent hand and finger movements, precise coordinated manipulation, and occasional kneeling, crawling, climbing, squatting, bending, and twisting; work at heights on scaffolding or ladders; and occasionally enter confined spaces.
Hearing acuity, color perception/discrimination, and far vision correctable to 20/30 in one eye and 20/100 in the other eye.
Ability to communicate and understand information presented verbally and in writing, and to follow written or oral instructions and procedures.

Responsibilities

Perform general housekeeping to pharmaceutical-operation standards.
Prepare process-area solutions and dispense cleaning and sanitization reagents for production areas and equipment.
Safeguard facilities, equipment, product, and coworkers; assemble, disassemble, and operate production equipment such as filters, vessels, skids, and columns.
Operate a forklift, CIP circuits, and process controls using the DCS.
Document production runs in real time and maintain accurate records and logs.
Perform integrity tests on sterile filters.
Prepare filter aid; install filters; set up transfer panels; assist with unloading bulk chemical tankers using the DCS; initiate chemical-loop circulation; and monitor solutions.
Receive and stage II+III paste, calibrate tank pH probes, prepare equipment, and harvest filter cake.
Prepare and test sterile filters, oscillate and sample sterile bulks, assist with initial sterile-bulk preparation, deliver bulks, and sterilize the bulk-tank-to-filter connection.
Assist with column regeneration, testing, and packing; clean and test U/F systems; use DCS and Unicorn control systems; assist with sterile-bulk formulation; calibrate pH and conductivity probes; install filters; and sample and test process solutions.
For Technician II, perform GMP and safety audits of the process area; prepare and operate production equipment to standards; troubleshoot production processes and equipment.
For Technician II, prepare buffer solutions, install filters, set up transfer panels, unload chemical tankers using DCS, test prepared solutions, circulate and monitor solutions, stage and add II & III paste, and calibrate tank pH probes.
For Technician II, prepare, oscillate, sample, and sterilize initial sterile bulks; assist with loading, evaluation testing, and packing of IGIV-C chromatography columns; clean and test UF/DF systems; monitor and control chromatography and UF/DF processes; formulate and test sterile bulks; calibrate probes; and install filters and UF cassettes in UF skids.