Your Role: Sr. Process Engineer. ManufacturingThe
Sr. Process Engineer is responsible for supporting the design, operation, control, and optimization of assets supporting technical processes at Elanco's Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. Serving as a subject matter expert (SME) for both processes and equipment, this role is deeply engaged in data analysis, troubleshooting, technology transfers, and continuous improvement activities. You will play a vital role in daily operations while also leading the design and delivery of local and major capital projects to ensure the site's technical success.
Your Responsibilities:- Technical Support & Troubleshooting: Provide engineering solutions for process and equipment issues, ensuring all systems are fit for purpose and provide on-floor support to manufacturing teams for root cause analysis and CAPA implementation.
- Regulatory & Quality Compliance: Ensure equipment and processes operate in a state of control in alignment with regulatory commitments, cGMPs, and Elanco standards, maintaining the qualified state of equipment through rigorous maintenance oversight.
- Data-Driven Optimization: Use performance and capacity analysis to identify, recommend, and implement improvements that optimize system performance.
- Capital Project Delivery: Support project teams in the delivery of local and major capital projects, participating in design, development, commissioning, qualification, and validation (CQV) activities.
- Documentation Excellence: Create, review, and revise critical technical documentation including User Requirement Specifications (URS), P&IDs, PFDs, and safety/environmental assessments.
- Safety & Hazard Mitigation: Participate in hazardous operations and process safety reviews to identify and mitigate risks, ensuring all operations comply with health, safety, and environmental policies.
- Cross-Functional Collaboration: Partner with team members to identify potential risks, sources of variability, and value engineering opportunities to maximize project return.
- Change Management: Prepare and execute change management plans and corresponding action items to ensure seamless process interventions.
What You Need to Succeed (minimum qualifications):- Education: Bachelor's degree (or equivalent) in a science or engineering discipline.
- Experience: 10 years of experience in the pharmaceutical, biotechnology, or a related regulated industry.
- Top 2 Skills: Strong analytical thinking and technical problem-solving skills; and a proven ability to prioritize and deliver results in cross-functional team environments with minimal supervision.
What Will Give You a Competitive Edge (preferred qualifications):- Direct experience in capital project design, development, and execution.
- In-depth understanding of monoclonal antibody (mAb) or recombinant protein manufacturing processes.
- Practical experience in commissioning, qualification, and validation (CQV) for aseptic processes and technology transfers.
- Proficiency with SAP, AutoCAD, Veeva Vault, and the application of RCI, FMEA, and QRM tools.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Additional Information:- Location: Elwood, Kansas
- Travel: Minimal (
- Schedule: This is a day-shift position; however, flexibility for weekend or evening work may be required to provide process support to ongoing manufacturing operations.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every qualification. At Elanco, we are committed to building a diverse and inclusive workplace. If you're excited about this role but your experience doesn't align perfectly with every qualification, we encourage you to apply. You may be the right candidate for this role-or another opportunity at Elanco.
Elanco Benefits and Perks: We offer a comprehensive benefits package focused on supporting your financial, physical, and mental well-being while empowering you to pursue our purpose. Highlights include:
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus opportunity
- Up to 6% 401(k) matching
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