Process Improvement Engineer I

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) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market.

Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.

It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.

Overview

Here at the OTI’s innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.

Support projects to improve the quality and efficiency of existing manufacturing processes as well as the scale-up, validation, and transfer of new products into manufacturing.

Snapshot of Responsibilities:

• Support the investigation and implementation of improvements to manufacturing processes to improve quality and efficiency, ensuring that all regulatory requirements are satisfied.
• Review manufacturing trending reports to ensure processes remain in control, assist manufacturing in investigating processes that yield product in specification but out of control limits.
• Investigate non-conformance conditions and implement corrective actions.
• Work with Product Development teams to facilitate the successful scale-up, transfer, and validation of new products.
• Prepare new or modify existing procedures as necessary for product/process improvements and new product transfers.
• Determine Critical to Quality (CTQ) attributes of products and processes. Establish trending requirements to monitor performance of CTQ’s.
• Support the development and execution of engineering and validation studies for process improvements and new products.
• Support the development and execution of qualifications for new or improved manufacturing processes.
• Ensure compliance with all pertinent safety and regulatory policies.

What you bring:

• B.S. degree in Engineering (ChemE (preferred), ME, or MfgE)
• 1-2 years of experience in a role responsible for process development and/or improvements for chemical or biological based products. Preferably with diagnostic assays, medical devices, or pharmaceutical products. Experience in new product development and technology transfer into manufacturing preferred.
• Well-developed knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, OneDrive, and Teams.
• Basic knowledge of Good Manufacturing Practices in a regulated industry preferred
• Demonstrated technical skill and experience in process validation and equipment qualification preferred.
• Good analytical and problem solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis. Six Sigma certification is a plus.
• Good communication skills, written and oral. Must be capable of giving and following written and oral directions.
• Technical writing skills including experience writing manufacturing documentation (Batch Records, Material Specs, Bills of Material, etc) preferred.
• Mechanical design proficiency using SolidWorks or equivalent 3D CAD system a plus.
• Experience as a project manager/planner, preferably using MS Project is a plus.
• Previous experience leading process improvement/new product transfer projects is a plus Experience with SAP or other similar ERP system is a plus.
• This role may include standing or sitting for extended periods, manipulating laboratory equipment, handling delicate instruments, and performing precise manual tasks. The role may involve the use of personal protective equipment (PPE) such as gloves, safety goggles, and lab coats. Additionally, employees in the role should expect occasional lifting, carrying, and transporting of laboratory materials(up to 25 pounds), as well as working with potentially hazardous substances following strict safety protocols.
• Travel may be required to support local Bethlehem, PA sites within a 10-mile radius. Additional limited travel upon request may be required for training, audits, or collaboration with other company locations or external partners.

OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong.

What we have to offer:

• Tiered Medical PPO, EPO, Vision and Dental coverage
• Disability and Life Insurance Benefits
• Generous 401K plan and company-matching contributions
• Highly competitive paid time-off
• Maternity Leave and Parental Leave Coverage
• Employee Referral Program – you may be eligible for a cash bonus if your referrals are hired
• Employee Assistance Program
• Employee Service Recognition
• Job-related Training Programs
• Ability to participate in Teams, Committees, Events and Clubs
• Depending on the role you may be eligible to work in a hybrid environment or fully remotely
• Free Onsite Parking

Please note, the above applies to full-time permanent positions.

Culture, People & Community

OTI recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and the OTI family of companies employees.

• LIVE IT Committee – committed to creating an environment that embodies our values
• All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book cluband mentorship program
• Wellness Committee empowers colleagues to make critical decisions to improve and protect health
• Sustainability Committee aims to minimize impact on the environment
• Social Committee who organize and run events for both remote and onsite employees, to create connection and community

At OTI, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by law with regard to any employment practices.

OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Katheryn Viau at [e-mail]. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.