JB061644 - Manufacturing Engineer

Unreal Gigs$70K — $95K *
Manufacturing & Automotive
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or equivalent experience with 3+ years experience
  • Strong understanding of IQ/OQ/PQ methodologies and validation lifecycle
  • Knowledge of medical device regulations including FDA and ISO 13485
  • Experience in manufacturing processes and equipment qualification
  • Familiarity with GMP, CAPA, and change control processes
  • Ability to read and interpret engineering drawings and technical specifications
  • Strong problem-solving and analytical skills

Responsibilities

  • Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment
  • Develop and review validation protocols in line with FDA regulations
  • Coordinate with cross-functional teams to ensure successful validation execution
  • Support equipment installation and troubleshooting activities
  • Maintain documentation and traceability for validation records
  • Perform risk assessments and contribute to process improvements
  • Participate in audits, inspections, and regulatory submissions

Benefits

  • Full-time onsite role in a regulated medical manufacturing facility
  • Opportunity to collaborate with cross-functional teams
  • Contributions to continuous improvement initiatives
  • Exposure to cleanroom environments and advanced manufacturing technologies
Full Job Description
  • Start Date: Interview Types
  • Skills FDA,IQ/OQ/PQ Visa Types H1B, Green Card, US ..


  • 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

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