Elanco
Process Engineer
Fort Dodge, IA
Sponsorship not specifiedDetected 8 hours ago
Data AnalysisComplianceProject ManagementBudgetingProcess ImprovementCustomer SupportGMPFDA RegulatoryLeadership
About the role
- improvements, data analysis, regulatory compliance, as well as commissioning, qualification and validation activities across the plant site.
- The process team member will play a key role in reducing variability and increasing reliability.
Responsibilities
- Process Improvement Project Management: Lead and execute process and equipment improvement projects, encompassing design, estimation, proposals, budgeting, and implementation, collaborating cross-functionally.
- Process Ownership & Expertise: Serve as the technical expert and asset steward for assigned processes and equipment, understanding design basis, control strategies, and potential manufacturing hazards.
- Equipment Lifecycle Management: Oversee equipment lifecycle from qualification through maintenance, including creating and approving preventative maintenance plans, utilizing statistical tools, historian charts, and root cause analysis to manage daily operations.
- Compliance & Documentation: Maintain and generate documentation adhering to cGMP, CAPA, Change Control, and other relevant regulations, including process flows, P&IDs, and equipment flow diagrams.
- Process and Project management experience including the responsibility for troubleshooting, hands-on scoping, design, configuration, validation, deployment or maintenance.
- Prior experience working closely with manufacturing personnel to develop process control requirements.
- 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.
Requirements
- Bachelor's degree in Engineering or equivalent experience.
- What You Need to Succeed (minimum qualifications):
Nice to have
- Experience in a fast paced cGMP working environment is a plus.
- Working knowledge of applicable regulations including cGMP, FDA 21 CFR Part 11, EU Annex 11 and NEC strongly desired.
- What Will Give You the Competitive Edge (preferred qualifications):
Compensation
- Annual bonus offering
Benefits
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- Annual bonus offering
- 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.
- Experience in a regulated industry such as animal health or human pharmaceutical.
- Elanco Benefits and Perks:
Company info
- At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
- 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.
- At Elanco, we are dedicated to building a diverse and inclusive work environment.
- We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose!
This listing is sourced directly from Elanco's careers page and normalized into a canonical job model.