Manufacturing Engineer

S4 Analytics LLC • Contract • Virginia, United States, US • 6d ago

Manufacturing Engineer (Pharma / Medical Device)

Location:Virginia - W2

Delaware (12 Months – FDA 483 Remediation)

Job Summary

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.

Key Responsibilities

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

Required Qualifications

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 SolidWorks
Basic understanding of PLCs and HMIs
Experience managing small-to-mid scale engineering projects

Preferred Qualifications