Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
Responsible for filling serials of antigen. Shall have an adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling. Must be able to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques.
DUTIES & ESSENTIAL JOB FUNCTIONS
Manufacturing and compounding sterile solutions and other parenteral classed products.
Obtaining, weighing, measuring and adding all raw materials as instructed on production procedures.
Set-up, operate and dismantle for cleaning, all equipment involved in the production process.
Accurately verify and document identity of all components used in formulation.
Responsible for assembling antigens into final product formulations and preparation of adjuvants or other intermediates.
Perform inspection and assessment of equipment and material condition prior to use. Determine when repair is necessary and follow up with appropriate documentation.
Sustained heavy lifting over extended periods of time.
Document operations with strict adherence to cGMP documentation practices.
Instruct workers of the lower grades as needed.
Be able to comprehend and follow Standard Operating Procedures/Filling Manufacturing Directions.
Fill sterile Parenterals and biologicals according to cGMP’s, SOP, and Filling Manufacturing Directions.
Follow Standard Operating Procedures for the handling of hazardous wastes.
Recognize documentation deficiencies and bring the deficiencies and required corrections to the supervisors and technicians.
May be subject to DEA background check.
Other Duties as Assigned
OTHER FUNCTIONS AND RESPONSIBILITIES
Assist higher Grade operators under supervision
May perform jobs of the lower grades as required
All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
High school diploma/GED
Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Additional Education and/or Equivalent Experience
Successful completion of National Career Readiness Work Keys assessment
Knowledge of Hazardous Waste Handling
Knowledge of Decontamination and Sterilization
Knowledge of Traffic Patterns
Knowledge of or evidence of working with BPE methods
Understanding of Basic GMP/Documentation practices
Demonstrated ability and understanding of Safe working habits
Understanding of Basic Laboratory Practices, Measurements, Biology and Microbiology
Understanding of operating in an aseptic environment
Ability to work in a team environment
Good verbal and written communication skills and ability to train others.
Perform calculations and conversions involving weights, volumes, and percentages
Ability to demonstrate problem solving and critical thinking
Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
Demonstrated understanding of systems, equipment, and processes
Ability to setup Fillers and trouble shoot mechanical issues
Experience with Windows Operating System.
Ability to work within several different computer systems and platforms. Computer aptitude that allows the person to adapt to future platforms and software
Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.