Senior Operations Engineer — Lean Manufacturing & Process Excellence

Evergen; Town of Florida, Northern (NY, KY); Hybrid; USD 115,000 - 130,000; Full time

Benefits offered by this job

PTO

401(k) with company match (up to 6%)

Holiday pay

Medical, dental, and vision insurance

Disability coverage

Job summary

Evergen, a leading regenerative medicine CDMO, seeks a Senior Operations Engineer in Alachua, FL. This full-time role validates and optimizes manufacturing processes, installs and validates control systems, and drives continuous improvement across lines and products.

The ideal candidate has 6+ years in process/equipment engineering, experience with Class III devices, and ISO 13485 familiarity. Benefits include PTO, 401(k) with company match, health coverage, and disability protection.

Qualifications

• 6+ years of engineering experience in designing, modifying, and implementing processes and equipment.
• Experience working with Class III medical devices.
• Experience working within an ISO 13485 regulated environment.
• Education requirements may be substituted for additional years of experience.

Responsibilities

• Validate equipment, understand interfaces and reactions of critical processes.
• Install and validate control systems; start, run, and upgrade processes.
• Provide manufacturing engineering support and recommendations for projects.
• Define and implement solutions to technical problems and document results.
• Lead development and improvement of manufacturing processes for existing and new products.
• Support or lead CAPA initiatives and non-conformances.
• Lead project management for multiple projects, including core team meetings and timelines.
• Support or lead capital equipment integrations for new lines and upgrades.
• Lead cross-functional teams on lean manufacturing, cost savings, and new product launches.
• Create documentation for standard operating procedures within the quality system.

Skills

MS Office

Advanced Excel

CAD software

Verbal and written communication

Project management

Problem solving

Technical writing

Statistics

Education

Bachelor's degree in engineering

Tools

CAD software

Job description

Evergen, a leading regenerative medicine CDMO, seeks a Senior Operations Engineer in Alachua, FL. This full-time role validates and optimizes manufacturing processes, installs and validates control systems, and drives continuous improvement across lines and products.

The ideal candidate has 6+ years in process/equipment engineering, experience with Class III devices, and ISO 13485 familiarity. Benefits include PTO, 401(k) with company match, health coverage, and disability protection.