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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.
- 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 or equivalent experience.
- 1+ years of industry experience
- Previous GMP manufacturing support experience.
- Previous process engineering and/or experience in capital delivery or project management.
- Well organized, strong communicator.
- Ability to lead cross-functional teams.
- Solid understanding of the cGMPs and all available technical resources (Corporate Policies and Procedures, Engineering Technical Guidelines, Project Delivery Manual, Master Specifications, drawing management, 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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