Advisor-Manufacturing Engineering

• 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.

• 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.

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.

• →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.

• 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.