Manufacturing Engineer - Validation & Process Improvement

JBL Resources; Pittsburgh (Allegheny County); On-site; USD 60,000 - 90,000; Full time

Job summary

JBL Resources is seeking a manufacturing engineer to lead validation and process improvement initiatives within a regulated environment. You will work on IQ/OQ/PQ, update SOPs, and coordinate with design and production teams to ensure smooth transfers.

The role requires up to 2 years in manufacturing engineering, experience with ERP systems like SAP or AS400, and a proven ability to manage multiple projects across locations while maintaining compliance with ISO 13485, ISO 9001, FDA or EUMDR.

Qualifications

• Bachelor’s degree in Mechanical, Industrial, Biomedical Engineering or related field.
• 0–2 years of manufacturing engineering experience focusing on validation, process development, and continuous improvement.
• Experience in regulated environments (Med Dev, Pharma, Biotech, Aerospace, or Defense).
• Experience with validation protocols (IQ/OQ/PQ) and documentation.
• Familiarity with ERP like SAP or AS400.

Responsibilities

• Lead validation efforts including IQ, OQ, and PQ protocols to ensure compliance.
• Collaborate with design teams to update process specifications and procedures.
• Manage multiple projects and drive initiatives to improve efficiency and reduce scrap.
• Coordinate production activities through cross-functional teams across locations.
• Analyze data and troubleshoot issues to sustain continuous process improvement.
• Document SOPs, work instructions, and validation protocols for regulatory compliance.
• Conduct process development and validation activities to support product transfer and sustainment.

Skills

Project ownership

Cross-functional collaboration

Process improvement

Documentation

Data analysis

Regulatory compliance

IQ/OQ/PQ validation

Education

Bachelor's degree in Mechanical/Industrial/Biomedical Engineering

Tools

SAP

AS400

PLM systems

SOP drafting tools

Job description

JBL Resources is seeking a manufacturing engineer to lead validation and process improvement initiatives within a regulated environment. You will work on IQ/OQ/PQ, update SOPs, and coordinate with design and production teams to ensure smooth transfers.

The role requires up to 2 years in manufacturing engineering, experience with ERP systems like SAP or AS400, and a proven ability to manage multiple projects across locations while maintaining compliance with ISO 13485, ISO 9001, FDA or EUMDR.