IGIV-C Technician I​/II; E630

The IGIV‑C Technician 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, cleaning, assembling and disassembling operating equipment per applicable procedures, assisting with process control manipulations and maintaining records/logs in accordance with current standard procedures.

• Performs general housekeeping in compliance with the high standards required of a pharmaceutical operation.
• Assists in the preparation of all solutions required for the process area and dispenses necessary cleaning/sanitization reagents to clean and sanitize production areas and equipment.
• Demonstrates the care and safety necessary to properly safeguard facilities, equipment, product and co‑workers. Assembles and disassembles production equipment. Operates production equipment (i.e. filters, vessels, skids, columns, etc.).
• Operates fork truck in a safe and efficient manner.
• Monitors and controls processes utilizing the DCS.
• Performs integrity tests on Sterile Filters.

• Buffer Prep
  
  Activities:
  
  Prepare filter aid for dispensing to zone 1, prepare and install filters, set up transfer panels and filters, assist in unloading of bulk chemical delivery tankers utilizing the DCS; initiate chemical loop circulation, monitor the state of solutions.
• Zone 1
  
  Activities:
  
  Receive and stage II+III paste, calibrate tank pH probes, prepare equipment and harvest filter cake.
• Zone 2 Sterile Processing
  
  Activities:
  
  Prepare and test sterile filters, oscillate and sample sterile bulks, assist in the preparation of initial sterile bulks, deliver bulks and sterilize the bulk tank to sterile filter connection.
• Zone 2 Purification Processing
  
  Activities:
  
  Assist in the regenerate, testing and packing of columns, assist in cleaning and testing U/F systems, utilize DCS and Unicorn control systems, assist in formulation of sterile bulks, calibrate tank pH and conductivity probes, prepares and installs filters for use, sample and test process solutions.

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

Education/Experience Requirements:
High school education or GED.

• Performs GMP and Safety Audits of Process area.
• Prepares and operates production equipment to standards (i.e. filters, column, bulk tanks, etc.).
• Troubleshoots and identifies problems with production processes and equipment.

• Buffer Prep:
  Prepare all buffer solutions and prepare and install filters, set up transfer panels for transfer to staging tanks, unload bulk chemical delivery tankers utilizing the DCS, sample and perform tests to determine acceptability of prepared solutions, initiate chemical loop circulation and monitor solutions.
• Zone 1:
  Stage and add II & III paste and calibrate tank pH probes.
• Zone 2 Sterile Processing:
  Prepare initial sterile bulks, oscillate, sample and sterilize bulks.
• Column Processing:
  Assist in loading, performing evaluation testing and packing IGIV‑C chromatography column.
• UF/DF Processing:
  Clean and perform evaluation testing of system, monitor and control chromatography and UF/DF process, assist in initial sterile bulk formulation, sample and test solutions, calibrate tank pH and conductivity probes, prepare and install filters and install UF cassette in UF skid.

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

Education Requirements:

Typically requires a minimum of 12 months as a Technician in his/her respective department before receiving consideration for advancement to IGIV‑C Tech II. Employee must receive a minimum of a meets expectations overall rating on his/her most recent performance review. Employee must have demonstrated competence to perform independently in at least one of the Process Areas listed above and also be…