Quality Engineering Leader — Sterility & GMP

Apio, Inc.; Chaska (MN); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical insurance plans

401(k) plan with company matching

PTO 4 weeks

HSA contribution

Paid holidays

Job summary

Lifecore Biomedical, LLC in Chaska, Minnesota, is seeking a Quality Engineering Manager to lead the quality system for clinical-stage manufacturing. You will develop, implement and maintain quality engineering and sterility assurance programs ensuring product conformance to regulatory requirements.

The role requires 8+ years in a regulated environment, a BS in Life Sciences or Engineering, and strong leadership of technical teams.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• 8+ years of progressive experience in a medical device, biopharmaceutical, or other highly regulated manufacturing environment.
• Experience in quality engineering, sterility assurance, and validation
• Experience leading technical teams
• Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceutical ingredients.
• Excellent organizational skills; capable of managing multiple dynamic, cross-functional projects simultaneously.
• Ability to provide effective technical and personnel leadership to ensure team accountabilities are completed in a timely and satisfactory manner.

Responsibilities

• Lead Quality Engineering team supporting the quality system and clinical stage production processes.
• Development and execution of process, equipment, sterilization and facility validation plans, protocols and reports.
• Approval or rejection of raw materials, components, labeling, in-process and finished goods.
• Review of production records and assurance of data integrity.
• Oversee creation of validation master plans for product, facility and critical processes, as well as the associated validation activity.
• Support internal and external audit activities.

Skills

Quality Engineering

Sterility Assurance

Leadership

Risk Management

Process Validation

Data Analysis

Technical Writing

Cross-functional Leadership

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

GMP regulations

FMEA

FTA

Process Validation

Job description

Lifecore Biomedical, LLC in Chaska, Minnesota, is seeking a Quality Engineering Manager to lead the quality system for clinical-stage manufacturing. You will develop, implement and maintain quality engineering and sterility assurance programs ensuring product conformance to regulatory requirements.

The role requires 8+ years in a regulated environment, a BS in Life Sciences or Engineering, and strong leadership of technical teams.