Lead CQV Validation Engineer for Life Sciences

Excel Engineering, Inc.; Mounds View, Northern (MN, KY); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

401(k) with employer matching

Health coverage

Dental & Vision

Life insurance

Paid time off

Flexible schedule

Job summary

Excel Engineering, Inc. seeks an experienced Validation Engineer to lead CQV activities for regulated manufacturing environments in pharma/biotech/medical devices. You will develop validation strategies, author protocols, and ensure regulatory compliance while guiding project teams and clients.

The role requires directing validation workstreams, mentoring junior engineers, and delivering projects on time and within budget in a fast-paced environment.

Qualifications

• Bachelor’s degree in chemical, biomedical, mechanical, electrical, or related discipline.
• 5–15 years of validation, commissioning, qualification, or related engineering experience in pharma/medical device manufacturing.
• Experience with automation systems, MES, SCADA, or computerized systems validation.

Responsibilities

• Lead and execute CQV activities for equipment, facilities, utilities, processes, and computerized systems.
• Develop and implement validation strategies using risk-based approaches.
• Author, review, and approve validation deliverables including validation plans/reports, URS, IQ/OQ/PQ protocols, and traceability matrices.
• Ensure compliance with cGMP, FDA, EMA, and applicable standards.
• Coordinate validation workstreams across engineering, quality, manufacturing, and project management teams.
• Mentor junior validation personnel and provide technical consultation to clients.

Skills

Validation

CQV

Regulatory knowledge

Lead projects

Mentoring

Client-facing

Education

Bachelor's degree in engineering or related scientific field

Tools

MES

SCADA

Validation software

Data acquisition

Statistical analysis tools

Thermal-mapping software

Job description

Excel Engineering, Inc. seeks an experienced Validation Engineer to lead CQV activities for regulated manufacturing environments in pharma/biotech/medical devices. You will develop validation strategies, author protocols, and ensure regulatory compliance while guiding project teams and clients.

The role requires directing validation workstreams, mentoring junior engineers, and delivering projects on time and within budget in a fast-paced environment.