Process Team and Validation Engineer - Elanco

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: Process Team and Validation Engineer

The process team member is responsible for the technical support for Production Operations with respect to the process, the equipment, troubleshooting, delivering capital improvements, data analysis, regulatory compliance, as well as commissioning, qualification and validation activities across the plant site. The process team member will play a key role in reducing variability and increasing reliability.

Your Responsibilities:

• Lead continuous improvement projects for processes and equipment, including design, estimation, proposals, budgeting, and implementation, sometimes acting as Project Manager.

• Serve as the subject matter expert for assigned processes and equipment, understanding design basis, control strategies, process hazards, and lifecycle management.

• Oversee equipment maintenance and monitoring throughout its lifecycle, including creating and approving preventative maintenance plans, using statistical tools and root cause analysis to manage daily operations, and ensuring proper qualification.

• Maintain and generate documents that ensure compliance with local, state, federal and international codes and regulations such as cGMP, CAPA’s and Change Control

• Utilize computer systems to troubleshoot processes, analyze data, and collaborate with operators, maintenance, and production teams for continuous improvement and safety enhancements.

What You Need to Succeed (Minimum Qualifications):

• Bachelor’s degree in Engineering or equivalent experience

• Prior experience working closely with manufacturing personnel to develop process control requirements.

• Must be effective in keeping lines of communication and information flow open, as interaction with others in this position is critical.

• Demonstrated analytical skills and problem solving skills - identifies problems; recognizes symptoms, causes, and alternative solutions; makes timely, sound decisions even under risk and uncertainty.

What Will Give You a Competitive Edge (Preferred Qualifications):

• Experience in a fast paced cGMP working environment.

• Process and Project management including the responsibility for troubleshooting, hands-on scoping, design, configuration, validation, deployment and maintenance.

• Working knowledge of applicable regulations including cGMP, FDA 21 CFR Part 11, EU Annex 11 and NEC.

• Experience in a regulated industry such as animal health or human pharma preferred.

Don’t meet every single requirement? Studies have shown underrepresented 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: · Multiple relocation packages

• 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