IGIV-C Technician I/II (E630)

Role Summary

The IGIV-C Technician I/II is responsible for the isolation of IgG by processing plasma intermediate paste and performing fundamental tasks within a GMP environment, including cleaning and maintaining the workplace, assembling/disassembling operating equipment, assisting with process control manipulations, and maintaining records/logs according to standard procedures. This role supports production across IGIV-C Technician I and II responsibilities within a rotating 12-hour shift.

Responsibilities

• Performs general housekeeping in compliance with pharmaceutical operation standards.
• Assists in preparation of solutions required for the process area and dispenses cleaning/sanitization reagents to clean and sanitize production areas and equipment.
• Assembles and disassembles production equipment; operates production equipment (filters, vessels, skids, columns, etc.).
• Operates forklift safely and efficiently.
• Operates CIP circuits and monitors/controls processes using the DCS.
• Performs real-time documentation during production and maintains accurate records/logs.
• Performs integrity tests on sterile filters.
• Buffer prep, zone 1/zone 2 processing activities, and purification processing activities as described, including preparing and testing filters, calibrating probes, and assisting with sterile bulks and chromatography-related tasks.

Qualifications

• Required: High School diploma or GED.
• Education/Experience: High school education or GED; typically requires 12 months as a Technician in the respective department before advancement considerations to IGIV-C Technician II; must have demonstrated competence in at least two process areas and independence in at least one.

Skills

• Basic math and computer skills; mechanical aptitude; detail-oriented; ability to work in a team and exercise good judgment.

Education

• High school diploma or GED (required).

Additional Requirements

• Occupational demands include lifting up to 50 lbs, standing/walking for long periods, rotating shifts, vaccination for hepatitis B, exposure to biological fluids, chemicals, and noise, and use of PPE. Ability to perform tasks in confined spaces and at heights, with frequent fine and gross motor tasks and adequate vision/hearing.