Your Role: Process EngineerThe Process Team Engineer is responsible for the technical support for Production operations with respect to the process, the equipment, troubleshooting, delivering capital
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.
Your 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.
- Safety & Project Leadership: Champion Elanco's safety-first culture, evaluating equipment for safety concerns and acting as a subject matter expert/project manager for capital and non-capital projects.
What You Need to Succeed (minimum qualifications):- Bachelor's degree in Engineering or equivalent experience.
- 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.
What Will Give You the Competitive Edge (preferred qualifications):- Experience in a fast paced cGMP working environment is a plus.
- Experience in a regulated industry such as animal health or human pharmaceutical.
- Working knowledge of applicable regulations including cGMP, FDA 21 CFR Part 11, EU Annex 11 and NEC strongly desired.
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 Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages for eligible roles
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Up to 6% 401K matching
