Technician I​/II

• Isolate IgG by processing plasma intermediate paste
• Clean and maintain the workplace within a GMP environment
• Clean, assemble and disassemble operating equipment according to procedures
• Assist with process control manipulations
• Maintain production records and logs
• Perform general housekeeping in a pharmaceutical operation
• Prepare process-area solutions and dispense cleaning/sanitization reagents
• Safeguard facilities, equipment, product and co-workers
• Operate production equipment including filters, vessels, skids and columns
• Operate a fork truck safely and efficiently
• Operate CIP circuits
• Monitor and control processes using DCS
• Perform real-time production documentation
• Perform sterile-filter integrity tests
• Prepare filter aid, filters, transfer panels and chemical loops
• Receive and stage paste, calibrate tank pH probes, prepare equipment and harvest filter cake
• Prepare, test, sample, oscillate and sterilize sterile bulks
• Assist with column regeneration, testing, loading and packing
• Clean and test U/F systems
• Use DCS and Unicorn control systems
• Formulate sterile bulks and test process solutions
• For Technician II: perform GMP and safety audits
• For Technician II: prepare and operate production equipment to standards
• For Technician II: troubleshoot and identify production-process and equipment problems
• For Technician II: monitor and control chromatography and UF/DF processes and install UF cassettes in UF skids

• High School diploma OR GED required
• Basic math skills
• Basic computer skills
• Mechanical aptitude
• Detail oriented
• Ability to work in a team environment and exercise good judgment
• Able to lift up to 50 lbs
• Able to stand/walk continuously during the shift
• Ability to work rotating shifts
• Required vaccination for hepatitis B due to exposure to plasma fractions
• Ability to work in a manufacturing environment with exposure to biological fluids, chemicals, electrical equipment, moving machinery, noise, dust/gas/fumes/steam, extreme cold, heights and confined spaces
• Ability to perform kneeling, crawling, climbing, squatting, standing, walking and bending
• Hearing acuity essential
• Color perception/discrimination required
• Far vision correctable in one eye to 20/30 and the other eye to 20/100
• Ability to understand and communicate information through spoken and written words
• Ability to follow written or oral instructions/procedures
• For advancement to IGIV-C Technician II: typically 12 months as a Technician in the respective department
• For advancement to IGIV-C Technician II: minimum meets-expectations overall performance rating
• For advancement to IGIV-C Technician II: demonstrated independent competence in at least one process area and proficiency in at least two process areas

Demonstrates proficiency in operating production equipment and performing process control manipulations within a GMP environment. Capable of maintaining detailed production records and adhering to safety and quality standards in a pharmaceutical setting.

• GMP Compliance
• Process Control Manipulation
• Production Equipment Operation
• Sterile-Filter Integrity Testing
• DCS and Unicorn Control Systems

• IgG Isolation
• CIP Circuit Operation
• Chromatography Process Monitoring
• Mechanical Aptitude
• Basic Math Skills

• Detail Oriented
• Team Collaboration
• Good Judgment
• Effective Communication

• High School Diploma or GED
• Hepatitis B Vaccination

• Pharmaceutical Operation
• Biological Fluids
• Cleaning/Sanitization Reagents
• Production Records
• Housekeeping

• DCS
• Unicorn Control Systems
• Production Equipment
• Fork Truck