Biotech Process Development Jobs in Indianapolis, IN

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.

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:

The Instrumentation and Calibration Engineer leverages their comprehensive understanding of measurement science and subject matter expertise to provide technical leadership and consultation to Elanco M&Q. This role serves as a strategic advisor to global sites, defining and harmonizing calibration standards to ensure manufacturing equipment and automated systems operate at peak precision and regulatory compliance.

As part of theGlobal Engineeringteam, you will ensure that our facilities producing pet and farm animal pharmaceuticals maintain the highest standards of operational excellence. While this is an advisory position focused on governance and continuous improvement, the successful candidate must possess the deep technical 'hands-on' background required to guide site teams, troubleshoot complex issues, and ensure that maintenance activities are executed with the urgency required to maintain a state of control.

Your responsibilities:

• Strategic Advisory- Serve as the primary technical advisor to global manufacturing sites on all matters related to instrumentation and calibration. Provide guidance on best practices for our diverse and specialized equipment across our Biotech and Small Molecule Networks.
• Standardization & Governance- Lead the development and implementation of harmonized global calibration standards and SOPs. Ensure consistency in how calibration is approached across M&Q to drive quality and efficiency.
• SAP PM & Operational Discipline- Act as the functional lead for SAP PM (Plant Maintenance) calibration modules. Define data integrity standards and optimize maintenance plans.Emphasize and monitor the critical importance of completing GMP preventive maintenance (PM) tasks within established windows to ensure continuous compliance and eliminate maintenance-related deviations.
• Auditing & Compliance- Conduct technical audits of site calibration programs to ensure alignment with Elanco global standards,USDA, ISO, FDA, and GMP requirements. Ensure robust NIST traceability and defend calibration programs during regulatory inspections.
• Technical Support & Troubleshooting- Provide high-level technical support for complex instrument failures or system malfunctions that exceed site-level capabilities. Lead root cause analysis (RCA) for significant calibration-related deviations and implement robust CAPAs to prevent recurrence.
• Continuous Improvement- Identify opportunities to upgrade outdated systems and implement innovative calibration technologies (e.g., paperless calibration, automated testing) to reduce downtime, improve accuracy, and streamline the PM lifecycle.
• Travel- Flexibility in domestic and international travel (approx. 30%) to visit manufacturing sites in support of advisory support, audits, and significant business initiatives.

What You Need to Succeed (minimum qualifications):

• B.S. degree in Instrumentation, Electrical Engineering, or a related technical field.
• Minimum of 5-8 years of experience in instrumentation and calibration within a biotech, pharmaceutical, or highly regulated GMP environment.
• Working knowledge of USDA and FDA regulatory requirements pertaining to animal health manufacturing.
• Strong foundational background in performing calibrations (multimeters, pressure calibrators, HART, etc.) to effectively advise others.
• Deep familiarity with biotech process instrumentation and control systems (PLCs, SCADA, Distributed Control Systems).
• Advanced proficiency in SAP PM as it relates to maintenance and calibration management.
• Must be a self-starter and capable of working independently with minimal direction.

What will give you a competitive edge (preferred qualifications):

• Significant experience (10+ years) in Animal Health, Pharmaceutical, or Biotech manufacturing environments.
• Proven ability to influence without authority and manage multiple assignments concurrently in a global, matrixed environment.
• Demonstrated ability to apply problem-solving methodology to complex technical situations within required deadlines.
• Understanding of validation activities, technology transfer, and process validation.
• Exposure to Lean Six Sigma principles.

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:

• Multiple relocation packages

• 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

• Flexible work arrangements

• Up to 6% 401K matching

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against jobrelated criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.