Kedrion Biopharma is a biopharmaceutical company 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 Inspection, Filling and Packaging and Hemin if required. In addition to making routine revisions to documents, technician may rewrite complex procedures or initiate new procedures as applicable.

Main Responsibilities

• Follow basic safety/EHS requirements, SOPs, cGMP, work rules and other company's policies. Perform removal of hazardous waste.

• Perform hands-on execution of manual and automated Fill/Finish operations from equipment preparation thru product inspection and packaging. Equipment includes autoclave, syringe filling machine and TUM, parts washer, semi-automatic inspection machine, packaging equipment, and material handling devices.

• Support Hemin activities when needed.

• Manual activities include equipment cleaning, room sanitization, equipment assembly and component replenishment, inspection, and packaging.

• Ensure production area is in the highest state of readiness

• Participate in the revision of Fill/Finish related documents.

• Participate on continuous improvement teams and implement continuous improvement tools.

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

• May perform other duties as assigned.

Background and Experience

• Associates degree preferred

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

• Must be flexible, able to work extended hours (overtime), and alongside multiple departments

Knowledge, Skills, and Abilities

• Good written and verbal communication skills

• Team player

• Self-motivator

• Good math skills and ability to perform calculations per batch record.

• Computer literacy and proficiency with Microsoft Office and e-mail a plus

• Sufficient technical competence to organize and lead production activities.

• Problem solving skills and results oriented.

Physical Requirements

• Ability to sit for extended periods of time

• Ability to bend, stoop or kneel.

• Ability to operate a computer keyboard, typewriter, and calculator.

• Ability to 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. Kedrion Biopharma offers a number of benefits to qualifying employees, including: - Medical, vision and dental insurance - Life and AD&D insurance - Paid holidays - PTO accrual - and much more! Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have! Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security. Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.