Senior Validation Engineer

Job Description

The Senior Validation Engineer position at Elanco involves conducting and managing commissioning and qualification efforts for equipment, utilities, and processes in the animal health industry.

Requirements

• BA or BS degree in a scientific discipline, related field, or comparable experience
• 5 years of experience in commissioning, qualification, and validation of cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment
• Specific knowledge of biological and pharmaceutical cGMPs (USDA and EU)
• Excellent verbal, written, interpersonal, and organizational and communication skills

Responsibilities

• Lead all validation activities and maintain the validation master plan for the site
• Manage and/or lead the validation team in all CQV activities to meet site goals and timelines
• Create commissioning, qualification, and validation documentation such as user requirement specification, design qualification, protocols, and final summary reports
• Conduct commissioning, qualification, and validation per approved Elanco corporate standards and protocols
• Collaborate with the system owner to define user requirements and establish an appropriate CQV strategy
• Support quality systems such as change control, deviations, CAPA, audits, quality metrics, annual product review, and person in plant

Benefits

• 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