Senior / Principal Engineer Visual Inspection - Parenteral Job at BioSpace in Indi

Overview 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 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 put people first and seek individuals determined to make life better for people around the world.

Responsibilities The Engineering Tech Center provides global technical expertise in Process Engineering and secondary / tertiary loop disciplines, including 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 and supports global manufacturing sites for the customer network, Global Facilities Delivery (GFD), development sites, as well as external manufacturing organizations and alliances.

Key Objectives / Deliverables

Technical and Discipline leadership – Partners with other technical staff to direct discipline activities, oversee the community, develop new technology, maintain Engineering Standards, Master specifications and Best Practices, and coach / mentor junior engineering staff.

Safety and Compliance – Ensure personal and team compliance with regulatory and corporate policy requirements; maintain appropriate safety practices to prevent injuries; ensure the ETC meets current Quality expectations and remains aligned with evolving Quality and regulatory expectations for engineering.

Consultation – Assist sites globally with technical evaluations, master planning, technology assessments, and problem resolution including troubleshooting and root cause analysis.

Knowledge sharing – Provide ongoing technical support to site engineering groups globally. Mentor Lilly engineers in technical development and functional capability building. Review and prepare protocols and technical reports.

External Influence – Monitor and, when appropriate, influence changes in external codes and standards; communicate learnings within Lilly and ensure ongoing compliance.

Major Capital Support – Provide technical consulting and leadership for Global Facilities Delivery on major capital projects; often lead multi-functional / multi-site project teams.

External Manufacturing Support – Provide technical consulting and leadership to Lilly’s external manufacturing partners; support due diligence, tech transfer, engineering batches, and deviation investigations; collaborate with cross-functional project teams with partners.

Platform Owner – Provide network technical leadership and ownership for designated equipment platforms or processes; align platforms across the network to maximize project delivery, operations, and maintenance efficiencies; develop relationships with Original Equipment Manufacturers (QEMs).

Innovation – Investigate and integrate emerging technology applicable to Parenteral manufacturing to meet production and compliance requirements.

Deliverables – Provide input and support for facility design, equipment layout, technical specifications, vision systems and equipment optimization, inspection testing, and qualification.

Basic Qualifications

Bachelor's degree in engineering or related technical field.

5-15+ years' experience in cGMP manufacturing or manufacturing support

Extensive knowledge of parenteral equipment (5+ years) and operations including automated, semi-automated and / or manual inspection equipment.

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 environment.

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.

Occasional work in a variety of manufacturing environments; safety equipment and / or gowning may be required.

EEO and Accommodation

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume, please complete the accommodation request form. This is for accommodation requests as part of the application process.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $63,000 - $165,000. Full-time employees may be eligible for a company bonus. Lilly offers a comprehensive benefits program including 401(k), pension, vacation, medical / dental / vision, flexible benefits, life insurance, leave benefits, and wellness programs.

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs. #WeAreLilly

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