Process Improvement Engineer I — Hybrid/Remote

OraSure Technologies, Inc.; Bethlehem (Northampton County); On-site; USD 62,000 - 107,000; Full time

Benefits offered by this job

Tiered medical coverage

401(k) with company match

Generous paid time-off

Parental leave

Employee referral program

Job summary

OraSure Technologies Inc. is seeking a Process Development Engineer to support manufacturing improvements, scale-up, transfer, and validation of new products in a regulated Bethlehem, PA setting. You will help optimize processes, write procedures, and collaborate with product development teams.

The role emphasizes data analysis, CTQ determination, and experience with DOE/DOE, SPC, RCA, and GMP practices, with opportunities for professional growth and a hybrid work environment.

Qualifications

• Bachelor's degree in Engineering required; ChemE preferred.
• 1–2 years in process development or improvement for chemical/biological products; diagnostics, medical devices, or pharma experience preferred.
• Strong knowledge of MS Office; familiarity with SharePoint/OneDrive/Teams.
• Basic GMP knowledge in regulated environments preferred.
• Experience in process validation and equipment qualification preferred.
• Strong analytical, problem-solving, and communication skills; DOE, SPC, and RCA experience a plus.

Responsibilities

• Support investigation and implementation of manufacturing process improvements to enhance quality and efficiency.
• Review manufacturing trending reports; assist in investigations for out-of-control processes.
• Investigate non-conformances and implement corrective actions.
• Collaborate with Product Development for scale-up, transfer, and validation of new products.
• Prepare or modify procedures for product/process improvements and new transfers.
• Determine CTQ attributes and establish trending requirements for monitoring performance.
• 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

Process development

Analytical reasoning

Statistical process control

Design of experiments

Root cause analysis

Project management

Communication skills

Education

Bachelor's degree in Engineering (ChemE preferred)

Tools

MS Project

SAP ERP

SolidWorks

MS Office

SharePoint

OneDrive

Teams

Job description

OraSure Technologies Inc. is seeking a Process Development Engineer to support manufacturing improvements, scale-up, transfer, and validation of new products in a regulated Bethlehem, PA setting. You will help optimize processes, write procedures, and collaborate with product development teams.

The role emphasizes data analysis, CTQ determination, and experience with DOE/DOE, SPC, RCA, and GMP practices, with opportunities for professional growth and a hybrid work environment.