Hybrid/Remote Manufacturing Process Excellence Engineer

Socket.dev; Bethlehem (Northampton County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Tiered medical coverage

401(k) with company match

Paid time off

Job summary

OraSure Technologies Inc. (OTI) is seeking a process-focused engineer to support manufacturing improvements and scale-up activities for diagnostic products. The role emphasizes GMP compliance, process validation, and data-driven decision-making.

You will collaborate with product development and manufacturing teams, analyze trends, and draft procedures to ensure efficient, high-quality transfers and new product introductions.

Qualifications

• B.S. degree in Engineering (ChemE preferred), ME, or MfgE.
• 1–2 years experience in process development/improvement for chemical or biological products (diagnostic assays, medical devices, or pharma preferred).
• Familiarity with GMP in regulated industry preferred.
• Experience with process validation and equipment qualification preferred.
• Strong analytical and problem-solving skills; knowledge of SPC, DOE, RCA; Six Sigma is a plus.
• Excellent written and verbal communication; capable of documenting manufacturing data.

Responsibilities

• Support investigations and improvements to manufacturing processes to improve quality and efficiency and ensure regulatory compliance.
• Review manufacturing trending reports and help keep processes in control.
• Investigate non-conformance and implement corrective actions.
• Collaborate with Product Development on scale-up, transfer, and validation of new products.
• Prepare and modify procedures for product/process improvements and transfers.
• Define CTQ attributes and establish trending for performance monitoring.
• Assist with qualification studies and regulatory safety adherence.
• Support safety/regulatory policy compliance and cross-functional audits.

Skills

Microsoft Office

Six Sigma

Statistical Process Control

Design of Experiments

Root cause analysis

Technical writing

Communication skills

SolidWorks

Project management

Education

B.S. in Engineering (ChemE preferred)

Tools

SAP

MS Project

SharePoint / OneDrive / Teams

3D CAD (SolidWorks)

Job description

OraSure Technologies Inc. (OTI) is seeking a process-focused engineer to support manufacturing improvements and scale-up activities for diagnostic products. The role emphasizes GMP compliance, process validation, and data-driven decision-making.

You will collaborate with product development and manufacturing teams, analyze trends, and draft procedures to ensure efficient, high-quality transfers and new product introductions.