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The Validation Engineer is responsible for design, development and execution of C&Q (Commissioning & Qualification) activities for facilities, utilities, and equipment at the Elwood, Kansas monoclonal antibody (mAb) manufacturing site. The position is a subject matter expert with respect to commissioning and qualification activities and ensures that systems are delivered, operate and are maintained in a constant state of qualification across the asset lifecycle. The Validation Engineer plays a key role in day-to-day operations as well as design and delivery of local and major capital projects on site.
Functions, Duties, Tasks:
Commissioning & Qualification Support
Provide leadership, coordination and support for planning and execution of commissioning, qualification and requalification activities of physical assets at the Elwood, Kansas mAb manufacturing facility including facilities, utilities, equipment, and computerized systems per Elanco and relevant regulatory expectations.
Collaborate with system owners to define user requirements, develop operating procedures, and establish an appropriate C&Q strategy.
Prepare, execute and review commissioning, qualification, and validation protocols / reports. Ensure completeness, accuracy and conformance to applicable Elanco, cGMP and regulatory standards.
Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
Provide input on facility, utility, and equipment design and modifications to resolve issues and ensure compliance with validation strategy.
Ensure qualification and verification activities are performed on schedule and in alignment with relevant project and validation master plans.
Support internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements, and guidance documents. Develop audit responses and complete assigned actions by target due dates.
Assist with development and maintenance of departmental and project budgets.
Support training of personnel and act as subject matter expert on protocol requirements, as well as general quality and validation principles. Develop validation knowledge and understanding across the site.
Demonstrate strict adherence to cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set.
Attend and complete necessary training as required in order to stay current with industry standards.
Project Delivery
Provide C&Q support to project teams, including delivery of local and major capital projects.
Participate in design, planning, execution, and qualification activities for capital projects. This includes, but is not limited to; definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, preparation and execution of commissioning, qualification and validation activities, etc.
Act as commissioning, qualification, and validation subject matter expert in project teams and committees.
Create, review and revise relevant documentation including C&Q plans, user requirement specifications, commissioning, qualification and validation protocols / reports, etc.
Prepare change management plans and complete corresponding action items.
Minimum Qualifications:
Bachelor’s degree (or equivalent) in a science or engineering discipline.
3+ years’ experience in the pharmaceutical, biotechnology, or a related industry.
Demonstrated expertise in commissioning and qualification of facilities, utilities and equipment in pharmaceutical and/or biotech settings.
Proven analytical thinking and problem-solving skills.
Working knowledge of cGMP standards and/or experience working in a regulated environment.
Demonstrated success operating in cross-functional teams.
Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
Strong verbal, written and interpersonal communication skills.
Strong organizational and computer skills.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Preferences:
5+ years’ experience in the pharmaceutical or biotechnology industry.
Experience in capital project delivery (design, development, and execution).
Understanding of monoclonal antibody / recombinant protein manufacturing processes.
Experience in commissioning and qualification activities associated with aseptic processes, technology transfers and new product commercialization.
Understanding and application of RCI, FMEA and QRM tools.
Previous experience with SAP, ERP, and Veeva Vault.
Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Other Information:
Location: Elwood, KS (Relocation provided for qualified candidates)
Shift: Day shift. Weekend and evening work not usual, although may be required to support some project and ongoing operations.
Travel: Minimal < 5%.
Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.
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
