Apply on Employer Site

Nuclein · 4 hours ago

Manufacturing Process Engineer

Austin, TX

Full-time

Onsite

Mid Level

3+ years exp

Nuclein is a company focused on developing innovative solutions in the medical device sector, and they are seeking a Manufacturing Process Engineer. The role involves supporting manufacturing production and product transfer for assay cartridges, as well as ensuring the on-time delivery of high-quality consumables while collaborating with various departments.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical Device

No H1B

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 3rd party compliance audits

Promote a safe working environment by enforcing safety protocols

Qualification

FDA regulationsCGMP guidelinesProcess validationTechnical problem resolutionManufacturing proceduresMS Office proficiencyProblem solvingDecision-making