Manufacturing Technician - Overnights
Company: Kedrion Biopharma
Posted on: May 3, 2021
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
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