Sr. Process Engineer, Manufacturing

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 (<5%)
• 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.