IGIV-C Technician I/II (E630)

Grifols•Clayton, NC

11d•Onsite

About The Position

The IGIV-C Technician isolates IgG by processing plasma intermediate paste and performs manufacturing tasks in a GMP environment. The role includes maintaining and cleaning the workplace, assembling and disassembling production equipment, assisting with process-control operations, and maintaining records and logs according to applicable procedures. The position works rotating 12-hour day and night shifts in a manufacturing environment. Technician I duties include housekeeping; preparing process solutions and cleaning or sanitization reagents; safeguarding facilities, equipment, products, and coworkers; operating production equipment, fork trucks, CIP circuits, and DCS controls; documenting production activities; and performing sterile-filter integrity tests. Additional assignments may include buffer preparation, Zone 1 paste handling, sterile processing, and purification processing. Technician II performs all Technician I duties and also conducts GMP and safety audits, prepares and operates production equipment to standards, and troubleshoots production-process and equipment problems. Additional assignments may include preparing and testing buffer solutions, handling paste, preparing sterile bulks, processing chromatography columns, and cleaning, testing, and operating UF/DF systems. The work takes place in a manufacturing environment with exposure to biological fluids and potential infectious organisms, chemicals, electrical manufacturing equipment, moving machinery, noise, dust, gases, fumes, steam, and temperatures below 32 degrees. Occasional confined-space entry and work at heights on scaffolding or ladders are required. Personal protective equipment is required. Hepatitis B vaccination is required due to exposure to plasma fractions.

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; at least a meets-expectations rating on the most recent performance review; demonstrated independent competence in at least one process area and proficiency in at least two process areas.
Ability to perform the physical and sensory demands described, including frequent hand and finger movements, precise coordinated manipulation, essential hearing acuity, specified corrected far vision, and color perception/discrimination.
Ability to communicate and understand information presented orally and in writing, and to follow written or oral instructions and procedures.

Responsibilities

Perform housekeeping and maintain production areas to pharmaceutical-operation standards.
Prepare process solutions and dispense cleaning and sanitization reagents.
Safeguard facilities, equipment, product, and coworkers.
Assemble and disassemble production equipment and operate filters, vessels, skids, columns, and other production equipment.
Operate a fork truck safely and efficiently, CIP circuits, DCS controls, and, where applicable, Unicorn control systems.
Monitor and control manufacturing processes and maintain real-time production documentation and accurate records and logs.
Perform integrity tests on sterile filters.
Prepare filter aid, filters, and transfer panels; assist with bulk chemical tanker unloading; initiate chemical-loop circulation and monitor solutions.
Receive, stage, and add 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; deliver bulks and sterilize bulk tank-to-filter connections.
Assist with regeneration, testing, and packing of columns; clean and test UF systems; assist with sterile-bulk formulation; calibrate pH and conductivity probes; prepare and install filters; sample and test process solutions.
Perform GMP and safety audits of the process area (Technician II).
Prepare and operate production equipment to standards and troubleshoot production processes and equipment (Technician II).
Prepare buffer solutions, sample and test solutions for acceptability, and set up transfer panels for staging-tank transfers (Technician II).
Prepare initial sterile bulks, oscillate, sample, and sterilize 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, and install UF cassettes in UF skids (Technician II).