Manufacturing Process Improvement Engineer I

Dnagenotek; Mount Carmel Township (PA); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Vision & Dental insurance

401K with company match

Paid time off

Job summary

OraSure Technologies Inc. is seeking a process development professional to support manufacturing improvements, scale-up, transfer and validation of new products. The role emphasizes CTQ definition, data analysis, and cross-functional collaboration to ensure quality and regulatory compliance.

You will work with Product Development teams and manufacturing to drive robust processes, write procedures, and support QA/QC activities in a regulated environment.

Qualifications

• Bachelor of Science in Engineering or related field preferred
• Experience in process development/improvement for chemical/biological products
• Familiarity with GMP and regulated environments
• Strong analytical and problem-solving skills

Responsibilities

• Support investigation and improvements to manufacturing processes to enhance quality and efficiency.
• Review manufacturing trending reports and assist in investigations for out-of-spec conditions.
• Lead or support scale-up, transfer, and validation of new products.
• Prepare and modify procedures for product/process improvements and transfers.
• Assist with CTQ attributes and trending related to product/process performance.
• Support engineering and validation studies for process improvements.

Job description

OraSure Technologies Inc. is seeking a process development professional to support manufacturing improvements, scale-up, transfer and validation of new products. The role emphasizes CTQ definition, data analysis, and cross-functional collaboration to ensure quality and regulatory compliance.

You will work with Product Development teams and manufacturing to drive robust processes, write procedures, and support QA/QC activities in a regulated environment.