FUJIFILM Holdings America Corporation · 1 week ago

Production Engineer

Santa Ana, CA

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $133K/yr

5+ years exp

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Responsibilities

Collaborate with team members to improve health, safety, and environmental processes.

Analyze and enhance efficiency, quality, and yield in manufacturing processes.

Troubleshoot production activities and ensure adherence to procedures and safety protocols.

Integrate new products seamlessly with manufacturing teams and optimize processes for successful launches.

Lead investigations into deviations and non-conformances, implementing corrective actions.

Utilize process knowledge to improve equipment functionality and manufacturing efficiency.

Support the implementation of new production equipment and develop departmental SOPs.

Maintain and improve accuracy of Bill of Materials and Electronic Batch Records.

Provide technical assessment during management of change process.

Qualification

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Manufacturing engineeringProcess engineeringProject engineeringCGMP Manufacturing Practice (GMP)Regulatory guidelinesFDA regulationsLife science productsQuality management systemInvestigation resolutionPreventative Action (CAPA)Change control proceduresLean ManufacturingSix SigmaWaste reductionProcess optimizationEnglish proficiencyCommunicationCustomer-orientedProblem-solvingTeamworkGMP ManufacturingBioprocessing EquipmentLife Sciences Industry

Required

Bachelor of Science in Chemical Engineering, or similar Scientific/Engineering background.

5-7 years of experience in manufacturing engineering, process engineering, project engineering, or similar role in a cGMP environment.

Understanding of Good Manufacturing Practice (GMP) regulations and guidelines set forth by regulatory agencies, such as the FDA, for the manufacturing of life science products.

Excellent communication and customer-oriented skills with ability to work in a matrix / cross-functional organization.

Knowledge and experience working within a quality management system, including investigation resolution, Corrective and Preventative Action (CAPA) implementation, and change control procedures.

Familiarity with and ability to apply concepts of Lean Manufacturing for waste reduction and process optimization, and Six Sigma for quality improvement methodologies.

Ability to speak, read, and write in English.

Good oral and written communication skills