Manufacturing Process Engineer

Position Summary:

The Manufacturing Process Engineer will be responsible for supporting manufacturing production, product transfer and research development required for assay cartridges in addition to production of Buffers, Inert Reagents, Lyophilized Reagents, and consumables that support the Nuclein production lines. This position will interface directly with Supply Chain, Quality Assurance, Research and Development, Quality Control, and Production personnel to the on-time delivery of high-quality consumables in line with company growth and supply demands. In addition, position will support the development, planning and execution of plans for the expansion of reagent and cartridge manufacturing capacity and capability.

Essential Duties and Responsibilities: 

·         Work directly with Operations supporting production reagents, and cartridge production lines.  Coordinates product testing with Quality Control and delivery with Operations. Position includes hands-on manufacturing as well as technical process development and optimization as needed

·         Provides technical support for reagent and consumable manufacturing processes.  Includes technical problem resolution, process validation, equipment identification and set up and procedure development.

·         Supports inventory materials and control processes with Supply Chain/Operations  models and ensure the needed equipment and materials are handled and stored correctly and  are available to meet production needs.

·         Performs MRB transactions for material movement as required.

·         Supports experiments and transfer as needed to support new diagnostic assays, equipment and facility changes and increased production volumes

·         Draft and release equipment and process validation protocols and reports where needed

·         Collates and analyzes metrics and develops then implements plans to address improvements for capacity and product quality.

·         Works with Operations and R&D to develop plans for needed manufacturing capacity and capability expansion including identification of equipment, facility and resource needs.

·         Participate in the development of facility, equipment and process requirements for reagent manufacturing 

 production area cleanliness, equipment calibration and maintenance

·         Assist with development of manufacturing procedures for new and on-market cartridge and reagent components

·         Ensure strict adherence to FDA regulations and GMP guidelines during reagent production

·         Assist with investigations and resolution of CAPAs and product non-conformances

·         Support 3^rd party compliance audits

        ·         Promote a safe working environment by enforcing safety protocols

Education, Qualifications, and/or Experience: 

·         Bachelor’s degree in Life Science or related field

·         3 – 5 years of experience in a medical device manufacturing environment preferred.

·         Experience operating under FDA regulations and cGMP guidelines such as CFR820 and ISO 13485-2016 is desired.

·         Problem solving and decision-making skills

·         Ability to operate independently with moderate supervision

·         Ability to prioritize tasks and engage other departments where appropriate

·        Proficient with MS Office suite or related software

Physical Requirements:  

·         Repetitive Motions including computer use and general lab activities

·         Weightlifting: < 25lbs

·         Position: Primarily Standing

·         Use of PPE will be required in the laboratory and manufacturing areas

THIS POSITION IS 100% ONSITE IN AUSTIN, TX. CANDIDATES MUST CURRENTLY LIVE WITHIN COMMUTING DISTANCE TO BE CONSIDERED. NO SPONSORSHIP IS BEING OFFERED AT THIS TIME.