Manufacturing Process Engineer

Nuclein•Austin, TX

4d•Onsite

About The Position

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.

Requirements

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
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.

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