At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
The Specialist (Operations Technician), Manufacturing is responsible for performing and documenting all tasks and activities associated with biologics manufacturing at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position will be expected to demonstrate a high level of technical competence, particularly with respect to fill / finish operations and the associated equipment sets. The specialist provides maintenance support and leadership on the production floor. This includes: mentoring / coaching, primary and secondary packaging equipment and line troubleshooting and data analysis, execution of work orders / PMs, analysis of packaging data, and investigation of packaging events. The specialist will use their in-depth knowledge of packaging systems to drive variability reduction and process / equipment improvements. Departmental goals include meeting quality and quantity production targets while maintaining compliance with Safety and Good Manufacturing Practice standards.
Functions, Duties, Tasks:
Manufacturing Operations
Execute and monitor critical processes for mAb manufacture, primarily with respect to primary (fill / finish) and secondary packaging activities.
Understands, performs and teaches others basic operation of production equipment and ensures all equipment, instruments and production materials are released and available for use. Look up and perform transactions within the electronic inventory and asset management systems.
Accurately follow SOP’s and batch production records in operation of production equipment, performance of processing steps, and execution of daily tasks.
Assemble, prepare, and maintain process equipment including, but not limited to: pumps, vial wash / depyrogenation oven, fill / finish units, labelling / packaging units and ancillary equipment.
Operate in a USDA / FDA / EMA cGMP regulated environment, maintaining strict adherence to all applicable regulations.
Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
Perform aseptic manipulations and demonstrate knowledge and experience of aseptic techniques.
Interface with the Quality Control department to submit samples and coordinate environmental monitoring during key process steps.
Assist Maintenance and Engineering personnel as necessary with equipment maintenance and calibration.
Identify and support the implementation of process improvement opportunities where applicable.
Participate in local projects.
Draft and review standard operating procedures (SOP’s), protocols, batch records, data summaries and reports.
Perform work safely, to Elanco quality standards, and maintain a safe, clean work environment.
Completes prescribed work under supervision or within clearly defined procedures.
Report Issues and Solve Problems
Recognize and solve typical problems that can occur in own work unit.
Track and evaluate in-process data to minimize manufacturing variability.
Report issues and events such as quality deviations, injuries/illnesses, etc.
Assist in improving safe working conditions by identifying / resolving hazards.
Troubleshoot equipment and process issues.
Assist in performing investigations for issues and events.
Minimum Qualification:
High School Diploma or equivalent.
3+ years’ experience in a regulated, commercial GMP biomanufacturing environment (relevant experience may include: aseptic processing, final formulation, fill / finish, secondary packaging).
Strong technical / equipment knowledge and troubleshooting skills.
Familiar with performing routine corrective and preventative maintenance with associated documentation.
Proficient reading, comprehension, and application skills toward a diverse set of complicated tasks.
Ability to accurately perform calculations, analyze, and process scientific data.
Demonstrated success working in a team environment.
Demonstrated ability and understanding of safe working habits.
Ability to work flexible hours as necessary to meet production demands and timelines.
Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.
Additional Preferences:
Associate of Science or Bachelor’s degree (or equivalent) in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.).
Previous experience with fill / finish and packaging equipment: experience in primary / secondary packaging operations.
Ability to use IT tools such as OSI PI, Veeva, CMMS (SAP).
Basic computer skills including experience with Windows Operating System and Microsoft Office products.
Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
Strong problem-solving skills, and experience performing / leading root cause investigations.
Strong verbal and written communication skills.
Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
Innovative spirit, strong initiative and work ethic, and positive attitude.
Able to follow written instructions and provide detailed documentation of work performed.
Other Information:
This is considered an on-site position.
This position may require occasional overtime.
Minimal travel may be required for training and equipment factory acceptance testing.
Influences peers within work unit.
Performs all Company business in accordance with all regulations (e.g. USDA, EMA, OSHA, etc.) and Company policy and procedures.
Elanco Benefits And Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Two week shut downs (mid-summer and year-end) in the US (in addition to PTO)
10-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Dependent and childcare support
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
