Manufacturing Engineer

Manufacturing Engineer (Pharma / Medical Device)

• Delaware (12 Months – FDA 483 Remediation)

We are seeking experienced Manufacturing Engineers to support pharmaceutical and FDA-regulated medical device manufacturing operations. The roles will focus on high-speed fill-finish environments (Virginia) and FDA 483 remediation, process risk analysis, and validation support (Delaware).

Candidates must have strong hands-on experience in automated manufacturing environments, quality systems, and process improvement initiatives within regulated industries.

• Support automated manufacturing operations in pharma/medical device environments
• Develop line layouts, fixture designs, and support 3D printing initiatives
• Conduct detailed process risk assessments and update PFMEAs
• Evaluate and implement mitigation controls across manufacturing processes
• Support validation activities including IQ, OQ, PQ, and TMV
• Review and update SOPs, Work Instructions, and DHF documentation
• Ensure alignment between documented procedures and actual production practices
• Drive process improvements and remediation activities
• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering)
• Support dimensional inspection, detection systems, capital equipment, and electromechanical assemblies

• Bachelor’s degree in Mechanical or Manufacturing Engineering
• 5–7 years of Manufacturing Engineering experience in FDA-regulated pharma or medical device environments
• Pharmaceutical high-speed fill-finish experience (Required for Virginia role)
• Strong knowledge of Quality Management Systems (QMS)
• Hands‑on experience with PFMEA, process risk analysis, and validation
• Experience in automated manufacturing environments
• Proficiency in AutoCAD and Solid Works
• Basic understanding of PLCs and HMIs
• Experience managing small‑to‑mid scale engineering projects

• Experience with filling and capping equipment
• Prior FDA inspection or 483 remediation experience
• Background in capital equipment or electromechanical product manufacturing

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