Apply on Employer Site

Evergen · 5 months ago

Operations Engineer 2

Alachua, FL, US

Full-time

Onsite

Mid Level

$80K/yr - $90K/yr

4+ years exp

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. The Operations Engineer 2 role involves validating equipment, supporting manufacturing processes, and leading continuous improvement efforts to enhance product quality and operational efficiency.

Health CareIndustrial ManufacturingMedical DeviceProduct Design

Responsibilities

Responsibilities involve validating equipment, understanding the interface and reactions of critical processes, and installing/ validating control systems Provides manufacturing engineering support and recommendations for direct projects in assigned areas

Defines and implements specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results

Writes and executes validation protocols and summary reports

Leads the development and improvement of the manufacturing process for existing and new products

Develops inspection plans for new and existing materials

Facilitates and drives quality remediation through partnerships with quality engineers

Supports or leads initiation, investigation, and closure of non-conformances and corrective and action preventative actions (CAPA)

Supports or leads projects to incorporate capital equipment for new manufacturing lines and upgrades to existing lines

Works cross functionally with teams for projects and initiatives including lean manufacturing, cost savings, added capacity, and new product launches

Operates within the company’s quality system to produce documentation for standard operating procedures

Leads continuous improvement efforts by performing time studies, value stream analysis, flow analysis and other lean related tasks

Makes recommendations and implements changes in support of the whole operations team to achieve team goals in quality, cost, delivery, and safety

Other duties as assigned

Qualification

Microsoft Office SuiteAdvanced ExcelComputer Aided DraftingProblem-solving methodologiesStatistical methodsProject managementTechnical writingContinuous improvementCommunicationTeam collaboration