Elanco is looking to solve the problem of ensuring the quality and compliance of their animal health products by hiring a Senior Validation Engineer to conduct and manage commissioning and qualification efforts for equipment, utilities, and processes.
Requirements
- 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.
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
Other
- BA or BS degree in a scientific discipline, related field, or comparable experience.
- Excellent verbal, written, interpersonal, and organizational and communication skills.
- Must be able to work in a diverse and inclusive work environment.
- Ability to relocate to Elwood, KS
- Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
