Validation Engineer: cGMP & Compliance Expert

Elanco; Elwood (KS); Presencial; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Elanco is seeking a qualified C&Q professional to coordinate commissioning, qualification, and verification activities at the Elwood, KS mAb facility, ensuring cGMP compliance and alignment with validation strategies.

You will collaborate with system owners, develop SOPs, and review protocols and reports while supporting audits and budgets. A Master’s degree and 2 years of regulatory/validation experience are required.

Qualificações

• Master’s degree in Information Technology, Computer Science, or related field and 2 years of post-baccalaureate experience in job offered or related roles.
• Regulatory knowledge across FDA, GMP, and ISO frameworks to control and improve processes.
• Technical writing and documentation to produce clear, user-friendly materials.
• Validation Protocols & Methodology to prove system/process meets specs and standards.
• Data Analysis and Statistics including JMP, Ellab Suite, Aveeva PI.
• Problem-Solving and Troubleshooting using 5 Whys, Ishikawa, Pareto charts.
• Risk Assessment (FMEA/Quality Risk Management) and associated activities.
• Software/Automation tools including Aveeva PI, SAP, and BMS.

Responsabilidades

• Coordinate planning and execution of commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at Elwood, KS.
• Collaborate with system owners to define user requirements, develop SOPs, and establish C&Q strategies.
• Prepare, execute, and review protocols and reports for C&Q and validation.
• Identify quality issues, perform root cause analyses, and manage CAPAs within the quality management system.
• Provide input on facility/equipment modifications to align with validation strategy and regulatory compliance.
• Oversee timely performance of qualification/verification activities with project plans.
• Support audits by regulatory bodies and corporate teams, developing audit responses and corrective actions.
• Contribute to budgeting and project planning; train personnel as SME on quality and validation standards.

Conhecimentos

Regulatory knowledge

Technical writing

Validation protocols

Data analysis

Problem solving

Risk assessment

Software/automation tools

Formação académica

Master’s degree in Information Technology, Computer Science, or related field

Ferramentas

JMP

Ellab Suite

Aveeva PI

SAP

BMS

Descrição da oferta de emprego

Elanco is seeking a qualified C&Q professional to coordinate commissioning, qualification, and verification activities at the Elwood, KS mAb facility, ensuring cGMP compliance and alignment with validation strategies.

You will collaborate with system owners, develop SOPs, and review protocols and reports while supporting audits and budgets. A Master’s degree and 2 years of regulatory/validation experience are required.