Job description

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 assembling and disassembling operating equipment such as filters, filter presses, vessels, etc., assisting with process control manipulations, maintaining records/logs and house cleaning per applicable procedures and in accordance with current standard procedures.

The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, within a GMP environment, by assembling and disassembling operating equipment such as filters, filter presses, vessels, Centrifuge, etc., assisting with process control manipulations, maintaining records/logs and house cleaning per applicable procedures and in accordance with current standard procedures.

The Filling Technician is responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals. The Technician must be Class A/B gowning qualified for facility cleaning of fill suites and will operate support fill equipment such as the glass inspection stations, rinser/tunnel, vial assembly and sterilization and over sealer in addition to loading carts with vials or syringes.

The Packaging Technician is responsible to detect and identify defect trends during the inspection of manufactured products in accordance with the PDA Lexicon and other applicable SOPs. Accurately inspecting and selecting product samples for both routine and non-routine quality and stability testing. In addition, but not limited to the set-up, operation, general maintenance of various equipment used in the Packaging department and house cleaning per applicable procedures and in accordance with current standard procedures.

• Depending on the specific type of Technician* key responsibilities could include:

· Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's)

· Assemble and disassemble production equipment

· Operate production equipment (i.e. filters, vessels, skids, columns, centrifuges, etc.) specific to the work area

· Operate CIP (Clean In Place) circuits

· Monitor and control processes utilizing automated control systems

· Perform integrity tests on Sterile Filters

· Perform in process analytical analysis

· Perform real time documentation during production run and maintains accurate records/logs

· May operate fork truck in a safe and efficient manner

· Assist 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

· Demonstrate the care and safety necessary to properly safeguard facilities, equipment, product and co-workers

· Perform general housekeeping in compliance with the high standards required of a pharmaceutical operation

Required Knowledge, Skills & Abilities:

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

Education Requirements for level I of Fractionation, Filling & Packaging Technicians:

· High School diploma. BioWorks Certificate Preferred

· For Packaging roles, Packaging Operator/Inspector experience preferred

Education Requirements for IGIV C Technicians:

· High School diploma OR GED required

· Bioworks Certificate or a high school diploma plus at least 1 year production manufacturing experience in a regulated industry (i.e. FDA, USDA, NRC) within the past 5 years or a 2 or 4 year college degree required

Work is performed in a manufacturing environment with rotating shifts or straight shifts depending on the area. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment and moving machinery. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32 as applicable*. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed standing, walking and bending neck for 6-8 hours per day. Frequently sits for 4-6 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Occasionally bends and twists neck and waist. Light lifting of 15lbs for 2-4 hours per day with a maximum lift of 50lbs. Hearing acuity essential. Color perception/discrimination, and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

EEO Minorities/Females/Disability/Veterans

Job Type: Full-time

Schedule:

• 4 hour shift
• 8 hour shift
• Day shift
• Evening shift

Work Location: In person

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