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Kedrion Biopharma, Inc. Fill Finish Aseptic Sterile Technician in Melville, New York

Kedrion Biopharma is a biopharmaceuticalcompany specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

Fill Finish Technician is responsible for the compliant execution of the manufacturing process strictly adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. Activities include manual tasks and operation of automated equipment. In addition to making routine revisions to documents, technician may rewrite complex procedures or initiate new procedures as applicable

Main Responsibilities

  • Perform hands-on execution ofmanual and automated Fill/Finish operations from equipment preparation,aseptic filling, thru product inspection and packaging. Equipment includesautoclave, syringe filling machine, COP cabinets, semi-automaticinspection machine, packaging equipment, and material handling devices.

  • Manual activities include equipmentcleaning, room sanitization, equipment assembly and componentreplenishment, inspection and packaging.

  • Compliant and safe operation ofprocessing equipment such as an autoclave, parts washer, aseptic filler,semi-automatic inspection machine, etc.

  • Ensure production area is in thehighest state of readiness

  • Act as manufacturing troubleshooterto resolve and communicate issues related to equipment, process, and complianceto the supervisor

  • Support or conduct deviationinvestigation

  • Develop and implement CAPA

  • Participate in the creation and revisionof Fill/Finish related documents.

  • Participate on continuousimprovement teams and implement continuous improvement tools.

  • Follow basic safety/EHSrequirements, SOPs, cGMP, work rules and other company's policies. Performremoval of hazardous waste.

  • Perform production area andassociated equipment recovery activities such as cleaning of rooms,filler, parts washer, miscellaneous equipment, etc.

  • May perform other duties asassigned.

Background and Experience:

Associates required or 2 years of relevant experience; Bachelor’s Degree preferred

2 Years’ Experience in pharmaceutical manufacturing is required and experience in aseptic or inspection/packaging is preferred.

Must be flexible, able to work extended hours (overtime), and alongside multiple department.

Knowledge, Skills, and Abilities

  • Good written and verbalcommunication skills

  • Team player

  • Self-motivator

  • Good math skills and ability toperform calculations per batch record.

  • Computer literacy and proficiencywith Microsoft Office and e-mail a plus

  • Sufficient technical competence to organizeand lead production activities.

  • Problemsolving skills and results oriented.

PhysicalRequirements:

  • Ability to sit forextended periods of time

  • Ability to bend,stoop or kneel.

  • Ability to operatea computer keyboard, typewriter and calculator.

  • Abilityto lift, tug, and pull up to twenty-five (25) pounds.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2. All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.

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