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):


* St...