Instrumentation and Calibration Engineering Advisor
Elanco · Indianapolis, IN · 5 days ago
ManufacturingFull-time
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 the Global Engineering team, you will ensure that our facilities producing pet and farm animal pharmaceuticals maintain the highest standards of operational excellence.
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- Continuous Improvement – Identify opportunities to upgrade outdated systems and implement innovative calibration technologies (e.g., paperless calibration, automated testing) to reduce downtime, improve accuracy, and streamline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.
- Flexibility in domestic and international travel (approx. 30%) to visit manufacturing sites in support of advisory support, audits, and significant business initiatives.
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.
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.