- Delivering changes to current manufacturing processes to improve the quality, cost, or throughput capabilities of IAPI, and/or
- Leading commercialization efforts to integrate new large molecule insulin products or product variants to IAPI production, and/or
- Delivering site infrastructure projects that enable the IAPI site to achieve business plan targets.
- Provide Design Lead oversight as needed, including:
- Establish user requirements and qualification plans to ensure that the equipment/system is appropriate for the intended purpose.
- Establish conceptual, basic, and detailed designs for capital projects. Perform reviews of contracted designs for technical accuracy.
- Feed process knowledge into the process design, utilizing tools such as modelling, historian data, technical reports, and industry literature.
- Provide Owner/User Representation as needed to ensure IAPI Operations or other Owner/Users are appropriately represented in all design, construction and verification activities. May include approvals on behalf of Operations or other Owner/User groups for project documentation, etc.
- Provide Operational Readiness as needed to ensure all site-driven operational readiness deliverables have been identified and performed to meet IAPI business schedule needs. Responsible for ensuring site performs all required activities post-construction to ensure asset is available for use per IAPI production timelines. This may include ensuring SOP/training readiness, organizational readiness, regulatory readiness, SAP preparedness, verification and validation planning and support, etc.
- Provide Project Leadership including:
- Collaborate with internal and external customers to manage integration of assigned projects with other site and network projects
- Provide regular communication to all levels of the organization via formal functional lead / steering teams and other ad hoc mechanisms.
- Develop and manage overall project timelines as well as progress metrics
- Lead cross-functional groups that enables the projects to move from inception to implementation.
- Bachelor's degree in engineering
- 5 + years of industry experience
- Previous pharmaceutical manufacturing support experience, and solid understanding of the cGMPs.
- Previous process engineering experience, and/or experience in major capital delivery or project management.
- Previous expertise in bulk chemical processing (expertise with tanks, pumps, piping systems, purification, fermentation, distillation, high purity water systems, etc).
- Well organized, strong communicator.
- Ability to lead cross-functional teams.
- Expertise working with available technical resources (Corporate Policies and Procedures, Engineering Technical Guidelines, Project Delivery Manual, Master Specifications, drawing management processes, etc).
- PE license and/or PMP certification.
- Normal working hours are day shift, Monday-Friday. Occasional off-hour coverage may be necessary due to planned implementations or emergency support.
- Periodic updates to Senior Manufacturing Leadership may be required
- Travel is expected to be less than 10%
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Makeup cannot be worn in manufacturing areas.
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Design Lead Engineer - Indianapolis, United States - Eli Lilly
Description
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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The design lead in IAPI (Indianapolis Active Pharmaceutical Ingredient) is responsible for providing owner/user representation, operational readiness leadership, and/or technical design oversight on large scale (>$5M) capital projects in partnership with Corporate Engineering.
Responsibilities:
Key Objectives/Deliverables:
Basic Requirements:
Additional Skills/Preferences:
Additional Information:
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
