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, but not limited to, 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

What You Need to Succeed (minimum qualifications): Education : BA or BS degree in a scientific discipline, related field, or comparable experience.

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, is required.

Prior experience related to equipment commissioning, qualification and validation is required.

Specific knowledge of biological and pharmaceutical cGMPs (USDA and EU) is required.

Must have excellent verbal, written, interpersonal, and organizational and communication skills.

Additional Information: Location: Elwood, KS

Don’t meet every single requirement? Studies have shown underrepresented 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

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching