IGIV-C Technician I/II (PFF)

Grifols•Clayton, NC

11d

About The Position

The IGIV-C Technician is responsible for isolating IgG by processing plasma intermediate paste and performing fundamental tasks in a GMP environment. The role includes maintaining a clean workplace, cleaning and maintaining equipment, assembling and disassembling operating equipment according to procedures, assisting with process controls, and maintaining accurate production records and logs. Technicians operate production equipment and systems, support processing activities across buffer preparation, Zone 1, sterile processing, and purification, and follow applicable safety and quality procedures. 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. The position is performed in a manufacturing environment on a 12-hour rotating shift. Work involves exposure to biological fluids, chemicals, electrical manufacturing equipment, moving machinery, noise, dust, gas, fumes, steam, and extreme cold. Hepatitis B vaccination is required due to exposure to plasma fractions. Personal protective equipment is required.

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 to stand and 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 minimum of a meets-expectations overall 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 work involving standing, walking, bending, frequent hand and finger movements, and occasional neck and waist bending and twisting.
Ability to work occasionally in confined spaces and to kneel, crawl, climb, squat, and work at heights on scaffolding or ladders.
Hearing acuity, color perception and discrimination, and far vision correctable in one eye to 20/30 and the other eye to 20/100.
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.
Safeguard facilities, equipment, products, and coworkers through appropriate care and safety practices.
Assemble and disassemble production equipment and operate filters, vessels, skids, columns, and other production equipment.
Operate a forklift safely and efficiently and operate CIP circuits.
Monitor and control processes using the DCS.
Complete real-time production documentation and maintain accurate records and logs.
Perform integrity tests on sterile filters.
Prepare filter aid, filters, transfer panels, and equipment for buffer preparation and processing activities.
Assist with unloading bulk chemical delivery tankers using the DCS, initiating chemical-loop circulation, and monitoring solutions.
Receive, stage, and add paste; calibrate tank pH probes; prepare equipment; and harvest filter cake in Zone 1.
Prepare, test, oscillate, sample, and assist with preparation and sterilization of sterile bulks; deliver bulks and sterilize bulk tank-to-filter connections.
Assist with regenerating, testing, loading, evaluating, and packing chromatography columns.
Clean and test ultrafiltration systems; monitor and control chromatography and UF/DF processes; assist with sterile bulk formulation; and sample and test process solutions.
Prepare buffer solutions, conduct acceptability tests, and set up transfer panels for transfer to staging tanks as applicable to Technician II duties.
Perform GMP and safety audits of the process area as a Technician II.
Troubleshoot and identify problems with production processes and equipment as a Technician II.
Install UF cassettes in UF skids and prepare and install filters for use as applicable to Technician II duties.