myGwork - LGBTQ+ Business Community · 3 days ago

Process Engineer

Indianapolis, IN

Full-time

Onsite

Mid, Senior Level

5+ years exp

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Responsibilities

Identify, define, and action long-term continuous improvement projects through partnership with site leadership and Operations team.

Evaluate process improvements to reduce cost, improve efficiency, and enhance quality.

Lead multiple project engineering assignments with sound project management methodologies.

Collaborate with Production to increase throughput by modifying workflow barriers and arrangements.

Provide technical specifications and supporting documentation for Engineering project designs and upgrades.

Complete deviation investigations, change controls, and corrective/preventative actions.

Serve as site system administrator for all automated equipment and routine maintenance.

Qualification

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GMPPharmaceuticalFood IndustryAutomation DesignProgrammingModelingTestingRoboticsClinical Packaging EquipmentGAMP 5GMP EnvironmentsBlister MachinesBottlingCardingSyringe AssemblyLean ManufacturingSix SigmaSMEDFailure AnalysisReliability EngineeringTechnical WritingRequirement SpecificationsFMEAsFAT/SAT/Commissioning ProtocolsSOPsWork InstructionsPLC Automation Control SystemLoop TuningSequential Function ChartsFunction Blocks

Required

Bachelor of Science Degree in Packaging, Mechanical, Industrial, Electrical Engineering or another scientific subject area from an accredited College or University required

5 Years Engineering experience in relevant GMP, pharmaceutical or food industry required

Preferred

Experience with designing, programming, modeling, and testing of automated systems including robotics and clinical packaging equipment to ensure code and configurations meet specifications and validation requirements strongly preferred.

Prior experience working within GAMP 5 and GMP environments strongly desired.

Experience with blister machines, bottling, carding, labeling, and syringe assembly preferred.

Must be results oriented and comfortable training, mentoring, and coaching peers and multi-functional team members.

Possess analytical skills in Lean Manufacturing, Six Sigma, and Single Minute Exchange of Dies (SMED) to enhance quality, reduce rejects, and streamline processes.

Experience with failure analysis and reliability engineering preferred.

Have strong technical writing skills with experience writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions desired.

Experience with PLC Automation control system start-ups, loop tuning, solving, and control system modifications is desired.

Experience developing sophisticated process control applications applying a mixture of programming formats including sequential function charts, function blocks and PLC ladder logic preferred.