Lead Validation Engineer - Life Sciences CQV & Compliance

Excel-Engineering,-Inc.; Mounds View (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Excel Engineering, Inc. seeks an experienced Validation Engineer to lead CQV activities in regulated manufacturing environments. You will develop validation strategies, author protocols, and ensure compliance with regulatory standards.

The role requires mentoring teams and coordinating across engineering, quality, and manufacturing functions. Ideal candidates have extensive CQV experience in pharma/medical devices, with strong leadership and client-facing capabilities.

Qualifications

• Bachelor’s degree in engineering or related science.
• 5-15 years of validation/ commissioning/ qualification experience in pharmaceutical or medical device manufacturing.

Responsibilities

• Lead and execute CQV activities for equipment, facilities, utilities, processes, and computerized systems.
• Develop validation strategies using risk-based approaches.
• Prepare and review Validation Plans, IQ/OQ/PQ, and Traceability Matrices.
• Ensure compliance with cGMP, FDA, EMA standards.
• Mentor junior engineers and coordinate cross-functional teams.

Skills

Leadership

CQV

Validation

Regulatory compliance

Project management

Client-facing

Mentoring

Technical reviews

Education

Bachelor’s degree in engineering or science

Tools

MES

SCADA

CSV

Job description

Excel Engineering, Inc. seeks an experienced Validation Engineer to lead CQV activities in regulated manufacturing environments. You will develop validation strategies, author protocols, and ensure compliance with regulatory standards.

The role requires mentoring teams and coordinating across engineering, quality, and manufacturing functions. Ideal candidates have extensive CQV experience in pharma/medical devices, with strong leadership and client-facing capabilities.