ApTask · 4 days ago

Process Engineer I

Frederick, MD

Full-time

Onsite

Mid Level

$40/hr - $43/hr

2+ years exp

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Responsibilities

Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.

Initiate quality records in the Veeva Quality Management System (QMS).

Lead cross-function team meetings to perform complex root cause analysis (RCA).

Compile investigation results in a concise and comprehensive technical report format.

Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).

Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.

Provide timely progress updates to internal stakeholders, as required.

Qualification

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Biochemical EngineeringChemical EngineeringBiotechnologyChemistryBiology6 years relevant experienceTechnical writingRoot cause analysisCell cultureAseptic processingCGMPManufacturingOrganizationProblem-solving

Required

BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience

AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience

HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent