Senior Process Improvement Engineer

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 our 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.  
Responsible for leading projects to improve quality and efficiency of manufacturing processes. Also responsible for leading the scale-up, validation, and transfer of new products into manufacturing. Responsibilities include: designing, executing, and documenting experiments, guard-band studies, generating Operations documentation for new products and validation of new processes and equipment.

Snapshot of Responsibilities

• Investigates and implements 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.
• Works with Product Development Teams to facilitate the successful scale-up, transfer, and validation of new products.
• Prepare new and modify existing procedures as necessary for product improvements and new product transfers.
• Determine Critical to Quality (CTQ) aspects of new products and ensure SPC charts are created and maintained to monitor performance of CTQ’s.
• Design and execute engineering and validation studies for process improvements and new products.
• Design and execute equipment qualifications for new manufacturing processes or improved manufacturing processes.
• Represent Operations on multiple new product development teams.  
• Ensure compliance with all pertinent safety and regulatory policies.

What You Bring

• B.S. degree in Engineering (Chemical Engineering, Biomedical Engineering or Mechanical Engineering).  MS preferred.
• 5 or more years experience as a process improvement scientist/engineer, manufacturing manager or equivalent position in a diagnostic assay or other medical device manufacturing area. 
• Experience in a variety of biochemical, immunological, microbiological, and molecular biology assay methods.
• Experience in new product development and technology transfer into manufacturing.
• Thorough knowledge of GMP’s
• Demonstrated technical skill and experience in process validation and equipment qualification.
• Excellent analytical and problem solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis.
• Good communication skills, written and oral. 
• Technical writing skills including experience writing manufacturing documentation (Batch Records, Material Specs, Bills of Material, etc).
• Experience with SAP or other similar ERP system.
• Good project management skills.
• Previous experience leading process improvement/new product transfer projects
• Six Sigma Black Belt certification preferred

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