IGIV-C Technician I/II

GRIFOLS, S.A.•NC-Clayton, CA

10d•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. This role involves working in a manufacturing environment with rotating shifts and exposure to biological fluids, chemicals, electrical manufacturing equipment, moving machinery, high levels of noise, dust/gas/fumes/steam, and extreme cold. Occasional entry into confined spaces and work at heights may be required, necessitating the use of personal protective equipment.

Requirements

High school diploma OR GED required
Basic math skills
Basic computer skills
Mechanical aptitude
Detail oriented
Ability to work in a team environment
Ability to exercise good judgment
Minimum of 12 months as a Technician in his/her respective department before receiving consideration for advancement to IGIV-C Tech II (Tech II)
Minimum of a meets expectations overall rating on his/her most recent performance review (Tech II)
Demonstrated competence to perform independently in at least one of the Process Areas and proficiency in at least 2 of the Process Areas prior to being considered for advancement to IGIV-C Technician II (Tech II)

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.
Prepares filter aid for dispensing to zone 1, prepares and installs filters, sets up transfer panels and filters, assists in unloading of bulk chemical delivery tankers utilizing the DCS; initiates chemical loop circulation, monitors the state of solutions.
Receives and stages II+III paste, calibrates tank pH probes, prepares equipment and harvests filter cake.
Prepares and tests sterile filters, oscillates and samples sterile bulks, assists in the preparation of initial sterile bulks, delivers bulks and sterilizes the bulk tank to sterile filter connection.
Assists in the regenerate, testing and packing of columns, assists in cleaning and testing U/F systems, utilizes DCS and Unicorn control systems, assists in formulation of sterile bulks, calibrates tank pH and conductivity probes, prepares and installs filters for use, samples and tests process solutions.
Performs GMP and Safety Audits of Process area (Tech II).
Prepares and operates production equipment to standards (i.e. filters, column, bulk tanks, etc.) (Tech II).
Troubleshoots and identifies problems with production processes and equipment (Tech II).
Prepares all buffer solutions and prepares and installs filters, sets up transfer panels for transfer to staging tanks, unloads bulk chemical delivery tankers utilizing the DCS, samples and performs tests to determine acceptability of prepared solutions, initiates chemical loop circulation and monitors solutions (Tech II).
Stages and adds II & III paste and calibrates tank pH probes (Tech II).
Prepares initial sterile bulks, oscillates, samples and sterilizes bulks (Tech II).
Assists in loading, performing evaluation testing and packing IGIV-C chromatography column (Tech II).
Cleans and performs evaluation testing of system, monitors and controls chromatography and UF/DF process, assists in initial sterile bulk formulation, samples and tests solutions, calibrates tank pH and conductivity probes, prepares and installs filters and installs UF cassette in UF skid (Tech II).