Validation Engineer

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your role:

Engineering and compliance oversight for equipment at Speke Site. Custodian of processes and systems that maintain the qualified state of Direct Impact equipment, facilities and utilities on site – specifically Controlled Temperature Storage (Temperature Mapping), Autoclaves, and Fume cupboard & safety cabinet qualification.

Additional support for Process Filtration, Direct Impact Utilities (e.g. high-grade water, steam and compressed gases).

Your responsible:

Technical knowledge

• Maintain a knowledge and understanding of regulatory expectations, industry best practices and global standard relating to temperature mapping and autoclave qualification.
• Know and understand the fundamental theory of applicable equipment / systems.
• Incorporate this knowledge into governing Standard Operating Procedures, and validation master plan.
• Review updates to corporate quality and Engineering standards and develop plans to address any identified site gaps.
• Represent the site in areas or responsibility at internal and external regulatory inspections.

Support Manufacturing

• Co-ordinate annual re-qualification programs and communicate standards and expectations to Product and support teams.
• Author qualification protocols and reports for applicable systems.
• Communicate compliance gaps / deviations to senior management. Raising deviations as required.
• Liaise with customers/key stakeholders to improve systems.

Safety and Environment

• Perform regular active monitoring to drive standards/expectations and identify safety issues.

Drive system improvement in close co-operation with customers/key stakeholders

• Identify need and opportunities for improvement and work with Product teams to develop and implement solutions
• Raise Change controls when required
• Support capital projects
• Define/agree commissioning and qualification requirements
• Review C&Q documents for applicable new equipment / facilities.

Establish internal corporate network and external contacts and develop professional expertise

• Belong to subject groups within Elanco
• Become point person/subject matter expert within Speke site for applicable systems
• Develop external focus, links to appropriate industry forums (e.g. ISPE, etc.).

What You Need to Succeed (minimum qualifications):

• Engineering or Science Degree.
• At least 3 years’ experience in pharmaceutical cGMPs
• Formal training in sterilisation principles and practises.

What will give you a competitive edge (preferred qualifications):

• Experience and/or training in HVAC systems and clean room standards
• Experience and/or training in GMP Facility Temperature Mapping

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 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