Manufacturing Engineer

Manufacturing Engineer (Pharma / Medical Device)

Location:

• Virginia (9–12 Months – Fill Finish Project)
• 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