Manufacturing Engineer in Salem

Job Description

JD-

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 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 of 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

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