Process Optimization Engineer I — Manufacturing & Diagnostics

OraSure Technologies; Bethlehem (Northampton County); Hybrid; USD 62,000 - 107,000; Full time

Benefits offered by this job

Tiered medical benefits

401K plan with company match

Paid time off

Job summary

OraSure Technologies Inc. seeks a talented engineer to support process improvements and scale-up for new and existing products. You will investigate processes, validate equipment, and collaborate with Product Development to ensure compliant, efficient manufacturing.

Candidate should have a B.S. in Engineering and 1–2 years of experience in process development. Familiarity with GMP, DoE, SPC, and SAP adds value. Occasional travel to Bethlehem area may be required.

Qualifications

• 1-2 years of experience in process development/improvement for chemical/biological products.
• Experience with diagnostic assays, medical devices, or pharma products preferred.
• Familiarity with GMP in regulated industry preferred.
• Experience with process validation and equipment qualification preferred.
• Knowledge of SPC, DoE, and root cause analysis; Six Sigma a plus.
• Excellent written and verbal communication skills; capable of following instructions.

Responsibilities

• Support investigation and implementation of manufacturing process improvements to enhance quality and efficiency while meeting regulatory requirements.
• Review manufacturing trending reports; assist in investigations for out-of-control processes.
• Investigate non-conformances and implement corrective actions.
• Collaborate with Product Development to scale-up, transfer, and validate new products.
• Prepare and modify procedures for product/process improvements and transfers.
• Define CTQ attributes and establish trending requirements for performance monitoring.
• Support engineering/validation studies for process improvements and new products.
• Support qualifications for new/improved manufacturing processes.
• Ensure compliance with safety and regulatory policies.

Skills

Analytical skills

Problem solving

Communication skills

Technical writing

Project management

MS Office proficiency

Statistical analysis

Education

B.S. in Engineering (ChemE preferred)

Experience in process development/improvement

Tools

SolidWorks

MS Project

SAP

SharePoint/OneDrive/Teams

Job description

OraSure Technologies Inc. seeks a talented engineer to support process improvements and scale-up for new and existing products. You will investigate processes, validate equipment, and collaborate with Product Development to ensure compliant, efficient manufacturing.

Candidate should have a B.S. in Engineering and 1–2 years of experience in process development. Familiarity with GMP, DoE, SPC, and SAP adds value. Occasional travel to Bethlehem area may be required.