Advisor-Manufacturing Engineering

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: Advisor, Manufacturing Engineering

Elanco Animal Health is seeking an experienced Senior CQV Engineer for our Central Engineering team to lead and execute validation lifecycle activities across bioprocessing equipment, clean utilities, cleanrooms, and facility systems in compliance with global standards, particularly EU GMP. Serving as a technical SME during capital projects, operational changes, and regulatory inspections, the role requires deep expertise in upstream and downstream bioprocesses, utility qualification, and hands-on troubleshooting.

Your Responsibilities:

• CQV Lifecycle Leadership: Author, review, and execute key validation deliverables (VMPs, URS, DQ, FAT/SAT, IQ/OQ/PQ) using ISPE risk-based verification approaches in full compliance with EU GMP (Annex 1 & 15) and FDA 21 CFR Part 211.
• Audit & Inspection Readiness: Serve as the on-site technical Subject Matter Expert (SME) during internal quality audits and external regulatory agency inspections.
• Bioprocess & Thermal Equipment Qualification: Lead the qualification and validation of critical upstream and downstream bioprocessing equipment, facility systems, and CIP/SIP cycles, ensuring alignment between CPPs and CQAs.
• Critical Utilities & Root-Cause Troubleshooting: Oversee CQV and monitoring for critical utility systems (WFI, PW, Clean Steam, Process Gases), leading technical root-cause investigations for excursions such as bioburden, microbial limits, and TOC spikes.
• Cleanroom & Environmental Mapping: Direct cleanroom classification (Grade A–D / ISO) and airflow smoke studies, while managing large-scale thermal mapping for cold rooms, freezers, incubators, and warehouses under static and loaded conditions.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• Experience: 8+ years of direct CQV or validation engineering experience within the biopharmaceutical, biotechnology, or pharmaceutical industry.

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

• Strong command of risk-based verification approaches such as ISPE Baseline Guide volume 5.
• Hands-on qualification experience with bioreactors, fermenters, single-use technologies, and autoclaves, with demonstrated success in scaling and troubleshooting cell culture or microbial systems.
• Proven diagnostic and root-cause troubleshooting capability resolving bioburden excursions and TOC spikes in WFI/PW distribution networks.
• Proficiency in environmental tracking and thermal validation hardware/software platforms.

Additional Information:

• Travel: Ability and willingness to travel 0-30% to support various manufacturing sites and vendor locations.
• Location: This role is based at our manufacturing location in Kiel, Germany.

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.