BioSpace · 2 days ago

Design Lead Engineer - Capital Projects

Indianapolis, IN

Full-time

Onsite

Senior Level

5+ years exp

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Comp. & Benefits

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Responsibilities

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.

Qualification

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Industry ExperiencePharmaceutical manufacturing supportCGMPsProcess engineeringCapital deliveryProject managementBulk chemical processingTanksPumpsPiping systemsPurificationFermentationDistillationHigh purity water systems lead cross-functional teamsPE licensePMP certificationNormal working hoursMonday-FridayOff-hour coveragePlanned implementationsEmergency supportTravel less than 10%Entering manufacturing areasLaboratory areasAppropriate PPEWell organized communicator

Required

Bachelor’s degree in engineering

5 + years of industry experience

Preferred

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.

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.