Quality Control /Environmental Monitoring Technician (R&D)
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!
Your Role: Quality Control /Environmental Monitoring Technician
Environmental Monitoring / QC Technician Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine environmental monitoring of the manufacturing facilities and associated utilities, as well as microbiology analysis.
Your Responsibilities:
Conducts Environmental Monitoring: Performs routine and non-routine sampling of manufacturing environments (air and surfaces) and utilities (WFI, USP Water, Pure Steam, Clean Compressed Air). Maintains gowning qualifications for sterile environments.
Ensures cGMP Compliance: Upholds cGMP, safety, and environmental standards within the QC lab, generating accurate and compliant data. Participates in internal assessments and audits.
Performs Microbiological Testing: Executes routine and non-routine analyses of raw materials, in-process materials, finished goods, and stability samples. Conducts a variety of microbiology tests, including bioburden, sterility, and microbial identifications.
Supports Investigations and Deviations: Assists in the investigation of out-of-specification/out-of-trend results, environmental monitoring excursions, and deviations. Contributes to the preparation of Certificates of Analysis.
Develops and Maintains QC Methods: Assists in developing, qualifying/validating, and transferring new test methods. Contributes to the writing and revision of testing methods, specifications, SOPs, and validation protocols/reports. Maintains lab inventory and performs routine equipment maintenance and cleaning.
What You Need to Succeed (minimum qualifications):
Education: High School Diploma/GED with 5years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
Experience: Technical skills in Environmental Monitoring to include, but not limited to, monitoring of manufacturing environment and utilities.
Excellent computer, documentation, communication, and organizational skills required.
What will give you a competitive edge (preferred qualifications):
Experience in cGMP environment preferred
Experience with environmental monitoring, water testing, sterility, and mycoplasma preferred.
Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities
Experience related to method development/validation.
Strong attention to detail, strong problem-solving skills, as well as, the ability to work in a cross-functional team environment.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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 weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
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
