VISUAL INSPECTION ENGINEER, ETC - PARENTERAL NETWORK

Company: BioSpace, Inc.
Location: Indianapolis
Posted on: October 30, 2024

Job Description:

Job Details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Responsibilities

The Engineering Tech Center is responsible for providing global technical expertise in the engineering sciences related to Process Engineering and secondary/tertiary loop disciplines. This includes knowledge and stewardship of the following: 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. This team 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.

This Visual Inspection Engineering position serves as a technical expert/resource in Parenteral Technologies for the inspection of semi-finished products globally and will be focused on the evaluation, delivery, implementation and support of automated, semi-automated and manual inspection equipment. Parenteral sites supported include Indy Parenteral (IPM), Fegersheim, Sesto, Suzhou, Research Triangle Park (RTP), Concord and Alzey. This position also applies technical knowledge to effectively guide and support Lilly's partner companies and contract manufacturers.

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. Basic Qualifications
  • Bachelors degree in engineering or related technical field.
  • 5-15 plus years in cGMP manufacturing or manufacturing support experience
  • Extensive knowledge of parenteral equipment and operations including automated, semi-automated and manual inspection equipment. Deliverables include input and support of facility design, equipment layout, technical specifications, vision system and equipment optimization, inspection testing and qualification. Additional Skills/Preferences:
    • 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.
    • Demonstrated ability to solve technical problems and implement projects. Other Considerations
      • Business title is subject to change depending on level
      • Must be able to travel up to 35% of the time with potential for more, US and international.
      • High potential for short term assignments (1-6 months) at Lilly or partner sites may be required
      • Will require occasional work in a variety of manufacturing environments; some safety equipment and/or gowning may be required.
        
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Keywords: BioSpace, Inc., Hamilton , VISUAL INSPECTION ENGINEER, ETC - PARENTERAL NETWORK, Engineering , Indianapolis, Ohio