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JB061644 - Manufacturing Engineer
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USM Business Systems
Marietta, GA (In Person)
Full-Time
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Job Description
USM Jobs / Manufacturing Engineer High Contract
JB061644
-Manufacturing Engineer Apply Start Date:
Interview Types SkillsFDA,IQ/OQ/PQ
Visa Types H1B, Green Card, US .. Job Description Apply for thisJob Key Responsibilities:
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes Develop, review, and execute validation protocols and reports in compliance with FDA and regulatory standards Coordinate with cross-functional teams (Quality, R D, Production, and Validation teams) for successful validation execution Support equipment installation, commissioning, and troubleshooting activities Ensure adherence to Good Manufacturing Practices (GMP) and quality systems Perform risk assessments (FMEA) and contribute to process improvements Maintain accurate documentation, traceability, and validation records Participate in process optimization and continuous improvement initiatives Support audits, inspections, and regulatory submissions as neededRequired Skills & Competencies:
Bachelor's degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience Strong understanding ofIQ/OQ/PQ
methodologies and validation lifecycle Knowledge of medical device regulations (FDA, ISO 13485) Experience in manufacturing processes, equipment qualification, and process validation Familiarity with GMP, CAPA, and change control processes Ability to read and interpret engineering drawings, P&IDs, and technical specifications Strong problem-solving and analytical skills Excellent communication and documentation skillsPreferred Qualifications:
Experience in medical device or regulated manufacturing environment Exposure to cleanroom manufacturing environments Familiarity with statistical tools and validation software Experience supporting automation systems or complex manufacturing equipmentWork Environment:
Full-time onsite role in a regulated medical manufacturing facility Requires collaboration with cross-functional teams and shop-floor presenceKey Deliverables:
ApprovedIQ/OQ/PQ
protocols and reports Equipment qualification and validation documentation Compliance with regulatory and quality standards Timely execution of validation and production readiness activities Name- Phone
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