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.

　　Validation Support Associate 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 the operation of automated equipment. In addition to making routine revisions to documents, technicians may rewrite complex procedures or initiate new procedures as applicable.

　　Main Responsibilities

　　Perform hands-on execution of manual and automated manufacturing operations. Equipment includes centrifuges, processing tanks set-up and operations, ultrafiltration systems, COP cabinets, CIP stations, and equipment assembly.

　　Assists in the execution and documentation of cleaning validation/qualification/verification activities.

　　Collects rinse and swab samples from various process equipment during cleaning validation and verification activities.

　　Material handling includes requesting, weighing and addition of chemicals, and suspending solid paste.

　　Correct and safe operation of equipment, chemicals, and product.

　　Ensure the production area is in the highest state of readiness.

　　Act as manufacturing troubleshooter to resolve and communicate issues related to equipment, process, and compliance to the supervisor.

　　Support or conduct deviation investigation.

　　Develop and implement CAPA.

　　Participate in the creation and revision of manufacturing-related documents.

　　Participate in continuous improvement teams and implement continuous improvement tools.

　　Follow safety/EHS requirements, SOPs, cGMP, work rules and other company policies.

　　Perform removal of hazardous waste.

　　Perform production area and associated equipment recovery activities such as cleaning of rooms, tanks, skids, miscellaneous equipment, etc.

　　Ensure all production materials and PPE are present as required.

　　Responsible for ensuring that the work area is maintained in a clean and orderly manner in accordance with cGMP and internal requirements.

　　May perform other duties as assigned.

　　Specific training plan to be provided.

　　Background and Experience:

　　Must be a Highschool graduate.

　　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

　　Identify and take on self-improvement opportunities.

　　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 stand/walk more than 75% of scheduled work time.

　　Ability to handle chemicals with proper PPE (Respirator) for buffer solutions.

　　Ability to work extended hours up to 12 hours if required.

　　Ability to gown into jumpsuits more than 4x/day.

　　Ability to work in -5C rooms for more than 2 hours/day.

　　Ability to walk up and down stairs more than five feet high, more than 5x/day.

　　Ability to clean Rooms for an entire shift.

　　Ability to Multitask Assignments

　　Ability to bend, stoop or kneel.

　　Ability to operate a computer keyboard and calculator.

　　Ability to lift, tug, push and pull up to fifty (50) pounds.

　　Training hours in March are 12pm - 8pm

　　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.