Manufacturing Engineer

Job Description: Role Summary:The Manufacturing Engineer will support equipment and process validation activities (IQ/OQ/PQ) for a medical device production facility.The role involves ensuring that manufacturing systems, equipment, and processes meet regulatory, quality, and performance standards while supporting production readiness and compliance.Key Responsibilities:Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processesDevelop, 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 activitiesEnsure adherence to Good Manufacturing Practices (GMP) and quality systemsPerform risk assessments (FMEA) and contribute to process improvementsMaintain accurate documentation, traceability, and validation recordsParticipate in process optimization and continuous improvement initiativesSupport audits, inspections, and regulatory submissions as neededRequired Skills & Competencies:Bachelor's degree in engineering (Mechanical / Electrical / Biomedical / Manufacturing) or equivalent experience with 3+ years' experienceStrong understanding of IQ/OQ/PQ methodologies and validation lifecycleKnowledge of medical device regulations (FDA, ISO 13485)Experience in manufacturing processes, equipment qualification, and process validationFamiliarity with GMP, CAPA, and change control processesAbility to read and interpret engineering drawings, P&IDs, and technical specificationsStrong problem-solving and analytical skillsExcellent communication and documentation skillsPreferred Qualifications:Experience in medical device or regulated manufacturing environmentExposure to cleanroom manufacturing environmentsFamiliarity with statistical tools and validation softwareExperience supporting automation systems or complex manufacturing equipmentWork Environment:Full-time onsite role in a regulated medical manufacturing facilityRequires collaboration with cross-functional teams and shop-floor presenceKey Deliverables:Approved IQ/OQ/PQ protocols and reportsEquipment qualification and validation documentationCompliance with regulatory and quality standardsTimely execution of validation and production readiness activities