Gamunex - IGIV-C Manufacturing Technician III 526888
Gamunex - IGIV-C Manufacturing Technician III 526888
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1 Vacancy
Job Description
Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
SHIFT: 12hour Rotating Shift
Summary:
The IGIVC 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 coworkers.
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 IIIII 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.
Knowledge Skills & Abilities:Basic math skills basic computer skills mechanical aptitude detail oriented ability to work in a team environment and exercise good judgment.
Requirements:
Basic math skills basic computer skills mechanical aptitude detail oriented ability to work in a team environment and exercise good judgment.
Education Requirements:
High School Diploma. Bioworks Certification preferred.
TECH II:
Primary Responsibilities:
Performs all duties described at IGIVC 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 IGIVC 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.
Occupational Demands:
Must be able to lift up to 50 lbs as well as stand/walk continuously during the shift and work rotating shifts. Required vaccination for hepatitis B due to exposure to plasma fractions.
Work is performed in a manufacturing environment with rotating shifts. 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*. 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 68 hours per day. Frequently sits for 46 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 24 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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.
Location:NORTH AMERICA : USA : NCClayton:USNC0002 Clayton
Required Experience:
IC
Employment Type
Full-Time
