JB061644 - Manufacturing Engineer

USM Jobs / Manufacturing Engineer High Contract JB061644 - Manufacturing Engineer Apply Start Date: Interview Types Skills FDA,IQ/OQ/PQ Visa Types H1B, Green Card, US .. Job Description Apply for this Job 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 needed Required Skills & Competencies: Bachelor's degree in Engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years experience Strong understanding of IQ/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 skills Preferred 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 equipment Work Environment: Full-time onsite role in a regulated medical manufacturing facility Requires collaboration with cross-functional teams and shop-floor presence Key Deliverables: Approved IQ/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 * Email * Phone * Visa Type * Select Visa Type H1B Green Card US Citizen H4 - EAD OPT CPT GC EAD TN - Trade NAFTA L2 EAD C2C/1099 TN Permit Holder Attach Resume * Choose file City * State Select AK AL AR AZ Byram CA CO Cokato CT DC DE FL GA HI IA ID IL IN KS KY LA Lowa MA MD ME Medfield MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK Ontario OR PA Ramey RI SC SD Sublimity TN Trimble TX UT VA VT WA WI WV WY Country United States Submit Information Locations Marietta, GA Position Open to Anywhere in the US, but will work on-site Industry Manufacturing Status Open Job Age 1 Day's Created Date 05/29/2026 No.of Positions 15 Duration 12 Zip Code