Global Validation Engineer — cGMP & Quality Systems

Elanco; Elwood (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Elanco is seeking a Quality & Validation professional to lead commissioning, qualification, and requalification activities at the Elwood manufacturing site. The role emphasizes regulatory compliance, documentation, and cross-functional collaboration with project teams.

You will perform risk assessments, develop QA documents, and support audits while ensuring state-of-the-art quality standards align with cGMP and corporate goals.

Qualifications

• Master’s degree in IT, CS, or related field, or foreign equivalent with 2 years post-bac experience.
• Regulatory knowledge across FDA, GMP, and ISO frameworks.
• Technical writing and documentation experience for clear, user-friendly materials.
• Validation protocols & methodology experience to prove systems meet specs.
• Data analysis using JMP, Ellab Suite, Aveeva PI.
• Risk assessment and FMEA knowledge and application.
• Software/automation tools including Aveeva PI, SAP, Ellab.

Responsibilities

• Coordinate commissioning, qualification, and requalification activities for facilities, equipment, and systems at the Elwood facility.
• Collaborate with system owners to define user requirements and C&Q strategies.
• Prepare, execute, and review C&Q protocols and reports compliant with cGMP.
• Identify quality issues and drive root-cause analysis and CAPAs.
• Provide technical input on facility/modifications to align with validation strategy.
• Oversee timely qualification activities and coordinate with project plans.
• Support audits and develop corrective actions as assigned.
• Contribute to budgeting and project planning for QA/QC.
• Train personnel and act as SME on quality and validation standards.
• Adhere to cGMP and safety standards and maintain training.

Skills

Regulatory knowledge

Technical writing

Validation protocols

Data analysis

Root cause analysis

Risk assessment

Software/automation tools

Education

Master’s degree in IT/CS or related field + 2 years experience

Tools

Aeveva PI

Ellab Suite

JMP

SAP

Job description

Elanco is seeking a Quality & Validation professional to lead commissioning, qualification, and requalification activities at the Elwood manufacturing site. The role emphasizes regulatory compliance, documentation, and cross-functional collaboration with project teams.

You will perform risk assessments, develop QA documents, and support audits while ensuring state-of-the-art quality standards align with cGMP and corporate goals.