Manufacturing Technician - Overnights

Company: Kedrion Biopharma
Location: Melville
Posted on: May 3, 2021

Job Description:

Job Description Manufacturing 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 of manual and automated manufacturing operations. Equipment includes centrifuges, processing tanks set-up and operations, ultrafiltration systems, COP cabinets, CIP stations, and equipment assembly. Material handling include requesting, weighing and addition of chemicals, and suspending solid paste. Correct and safe operation of equipment, chemicals, and product. Ensure 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 on 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 to assure 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 Background and Experience: Must be a high school graduate or have a GED 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 taken 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. Adaptable to change 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 5 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, typewriter and calculator. Ability to lift, tug, push and pull up to fifty (50) 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Company Description 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.

Keywords: Kedrion Biopharma, New Haven , Manufacturing Technician - Overnights, Other , Melville, Connecticut