IGIV-C Technician I/II (E630)

Grifols•Clayton, NC

5d•Onsite

About The Position

The IGIV-C Technician is responsible for the isolation of IgG by processing plasma intermediate paste and performing fundamental tasks within a GMP environment by 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. TECH I: Primary Responsibilities: 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. Operates CIP circuits. Monitors and controls processes utilizing the DCS. Performs real time documentation during production run and maintains accurate records/logs. Performs integrity tests on Sterile Filters. Additional Responsibilities: 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. TECH II: Primary Responsibilities: Performs all duties described at IGIV-C Technician level. 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. Additional Responsibilities: 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.

Requirements

High School diploma OR GED required
High school education or GED
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 proficient in at least 2 of the Process Areas listed above prior to being considered for advancement to IGIV-C Technician II.

Nice To Haves

Basic math skills
Basic computer skills
Mechanical aptitude
Detail oriented
Ability to work in a team environment
Exercise good judgment

Responsibilities

Isolation of IgG by processing plasma intermediate paste
Cleaning and maintaining the workplace
Cleaning, assembling and disassembling operating equipment per applicable procedures
Assisting with process control manipulations
Maintaining records/logs in accordance with current standard procedures
Performs general housekeeping in compliance with high standards
Assists in the preparation of all solutions required for the process area
Dispenses necessary cleaning/sanitization reagents to clean and sanitize production areas and equipment
Demonstrates 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
Operates CIP circuits
Monitors and controls processes utilizing the DCS
Performs real time documentation during production run and maintains accurate records/logs
Performs integrity tests on Sterile Filters
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
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 in the preparation of initial sterile bulks
Deliver bulks and sterilize the bulk tank to sterile filter connection
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
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
Prepare all buffer solutions
Set up transfer panels for transfer to staging tanks
Sample and perform tests to determine acceptability of prepared solutions
Stage and add II & III paste
Prepare initial sterile bulks, oscillate, sample and sterilize bulks
Assist in loading, performing evaluation testing and packing IGIV-C chromatography column
Clean and perform evaluation testing of system
Monitor and control chromatography and UF/DF process
Assist in initial sterile bulk formulation
Calibrate tank pH and conductivity probes
Prepare and install filters
Install UF cassette in UF skid