Manufacturing Engineer

Job Title

Manufacturing Engineer (Pharma / Medical Device)

Contract (W2 Only)

We are seeking experienced Manufacturing Engineers to support pharmaceutical and FDA‑regulated medical device manufacturing operations. This role will focus on high‑speed fill‑finish manufacturing environments, process improvement initiatives, validation support, and quality remediation activities within regulated industries.

The ideal candidate will have hands‑on experience in automated manufacturing environments, quality systems, validation, and process risk analysis.

• Support automated manufacturing operations in pharmaceutical and medical device environments
• Develop manufacturing line layouts, fixture designs, and support 3D printing initiatives
• Conduct process risk assessments and update PFMEAs
• Implement mitigation controls across manufacturing processes
• Support validation activities including:
  • IQ
  • OQ
  • PQ
  • TMV
• Review and update SOPs, Work Instructions, and DHF documentation
• Ensure manufacturing documentation aligns with production practices
• Drive process improvement and remediation initiatives
• Collaborate with Manufacturing, Quality, and Engineering teams
• Support dimensional inspections, detection systems, capital equipment, and electromechanical assemblies

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related field
• 2+ years of Manufacturing Engineering experience in FDA‑regulated pharma or medical device environments
• Experience in high‑speed fill‑finish manufacturing environments
• Strong understanding of:
  • Quality Management Systems (QMS)
  • PFMEA
  • Process Risk Analysis
  • Validation Activities
• Hands‑on experience in automated manufacturing environments
• Proficiency with:
  • AutoCAD
  • Solid Works
  • Basic understanding of PLCs and HMIs
• Experience supporting engineering projects and process improvements

• Experience with filling and capping equipment
• Prior FDA inspection or 483 remediation experience
• Background supporting capital equipment or electromechanical manufacturing operations
• Strong troubleshooting and documentation skills

• 2+ years of relevant Manufacturing Engineering experience in regulated industries