Sr. Principal Process Engineering SME, Parenteral

Overview

The Engineering Tech Center at Lilly provides global technical expertise in engineering sciences related to Process Engineering and secondary/tertiary loop disciplines. This includes knowledge and stewardship of First Principles, unit operations, Equipment Flow Diagrams, Capability Calculations, Material & Energy Balances, Facilities (fitness for use), Root Cause applications, Equipment and Unit Operation Changes/Improvements including new technologies, Scale-ups, Periodic Reviews, Process Safety, Maintenance/Reliability, etc. This function has a global presence.

Responsibilities

• Provides engineering support to global manufacturing sites for the customer network, Global Facilities Delivery (GFD), development sites, as well as external manufacturing organizations and alliances.
• Serves as a technical resource in Aseptic Processing and Parenteral Technologies such as Equipment Preparation, Formulation, Filling, Freeze Drying, and Isolation systems, providing expert process engineering support globally.
• Applies technical knowledge to effectively guide and support Lilly's partner companies and contract manufacturers as well as mentor other engineers.

Key Objectives/Deliverables

• Technical and Discipline leadership – Partners with other technical staff to direct discipline activities, oversight of the community, new technology development and technology assessments, creation and maintenance of Engineering Standards, Master specifications and Best Practices for the discipline, and coaching and mentorship of junior engineering staff.
• Safety and Compliance – Ensure personal and team compliance with all applicable regulatory and corporate policy requirements; ensure appropriate safety practices and procedures are in place and are followed to prevent injuries; ensures the ETC meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to engineering.
• Consultation – Assists sites globally with technical evaluations, master planning, technology assessments, and specific problem resolution including troubleshooting and root cause analysis.
• Knowledge sharing – Provides ongoing technical support to site engineering groups, domestic and global. Serves as a mentor to Lilly engineers with a focus on technical development and functional capability building. Interfaces with and develops site technical experts in Parenteral Engineering.
• Reviews and prepares protocols and technical reports.
• External Influence – Monitors and, when appropriate, influences change in external codes and standards on Lilly’s behalf. Ensures external learnings are effectively communicated within Lilly and works to ensure ongoing compliance with these learnings.
• Major Capital Support – Provides technical consulting and leadership, both conceptual and detailed design, to Global Facilities Delivery on major capital projects. Will often lead multi-functional/multi-site project teams.
• External Manufacturing Support – Provides technical consulting and leadership to Lilly’s external manufacturing partners. Responsibilities will be range from due diligence, tech transfer, engineering batches to deviation investigation support. Will work closely with cross-functional projects teams managing the relationships with our partners.
• Platform Owner – Provides Network technical leadership, oversight, and ownership for designated equipment platforms or processes. Influences platform alignment across the Network to maximize project delivery, operational and maintenance efficiencies, and replicated cost benefits. Develops strong relationships with our Original Equipment Manufacturers (QEMs) and leverages these partnerships as we develop new designs, trouble-shoot equipment issues and maintain our equipment.
• Innovation – Investigates, develops, and integrates emerging technology and capabilities applicable to the Parenteral manufacturing process to meet production and compliance requirements.

Qualifications

• Bachelor's degree in engineering or related technical field.
• Minimum 10 plus years in cGMP manufacturing or manufacturing support experience with increasing technical responsibility.

• Extensive knowledge of parenteral processing equipment and operations including formulation, filling, freeze drying, and isolation equipment.
• Demonstrated ability to solve technical problems and implement projects. Deliverables include input and support of facility design, equipment layout, technical specifications, and equipment optimization, testing and qualification.
• Familiarity with technology advances in vial, cartridge, and syringe container closure systems.
• Strong interpersonal and communication skills to be effective in a team-based situation.
• Ability to work across boundaries (functional, geographic, external company, etc).
• Demonstrated learning agility.
• Ability to work effectively with outside suppliers.