Validation Engineer - Pharmaceutical Manufacturing

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

Description

Excel Engineering, Inc. is a full-service engineering consulting firm specializing in electrical engineering, industrial automation, power systems, and validation. For over 30 years, we’ve partnered with leading companies across industries to deliver solutions that improve safety, efficiency, and performance. Our work spans sectors including life sciences, consumer goods, chemical, oil & gas, and utilities, giving our team the opportunity to work on complex, high-impact projects.

We are seeking an experienced Validation Engineer to lead and execute commissioning, qualification, and validation (CQV) activities for regulated manufacturing environments in the pharmaceutical, biotechnology, medical device, and other life sciences industries.

This role serves as a technical leader responsible for developing validation strategies, authoring and executing qualification protocols, and providing guidance to project teams and clients. This role independently manages validation workstreams, mentors junior engineers, and drives project success by ensuring compliance with regulatory requirements and industry best practices.

Key Responsibilities

• Lead and execute commissioning, qualification, and validation 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 and Reports, User Requirements Specifications (URS), Risk Assessments, Technical Specifications, IQ/OQ/PQ Protocols, and Traceability Matrices.
• Ensure compliance with cGMP, FDA, EMA, and applicable industry standards.
• Support investigations, deviations, CAPAs, and change control activities.
• Lead validation workstreams for small to medium-sized projects.
• Develop schedules, budgets, and resource plans for assigned activities.
• Coordinate efforts across engineering, automation, quality, manufacturing, and project management teams.
• Identify project risks and implement effective mitigation strategies.
• Drive projects to meet quality, schedule, and budget objectives.
• Serve as a subject matter expert in one or more validation disciplines: Facility, Utility, and Equipment Qualification; Process Validation; Cleaning Validation; Sterilization Validation; Computerized Systems Validation (CSV).
• Evaluate and apply regulatory requirements and industry best practices.
• Provide technical consultation to clients and internal stakeholders.
• Mentor and coach junior validation personnel.
• Perform technical reviews of project documentation.
• Promote standardization, continuous improvement, and best practices across teams.
• Contribute to training and professional development initiatives.

Requirements

Education

• Bachelor’s degree in chemical, biomedical, mechanical, computer, electrical, or another relevant engineering or scientific discipline.

Experience

• 5-15 years of validation, commissioning, qualification, or related engineering experience in pharmaceutical or medical device manufacturing.

Preferred Qualifications

• Experience supporting large capital projects and facility start-ups.
• Experience with automation systems, MES, SCADA, or computerized systems validation.
• Experience using validation lifecycle, quality management, data acquisition, statistical analysis, or thermal-mapping software.
• PMP, CQV, ASQ, or related professional certifications.
• Experience serving as a client-facing technical lead.
• Engineer in Training (EIT) certification or eligibility to obtain it.
• Ability to travel up to 10%.
  

We offer…

Growth & Development: Ongoing continuing education, hands-on training, and opportunities to expand your skills.

Career Advancement Support: Assistance in earning professional certifications and pursuing further education.

Retirement Benefits: 401(k) plan with employer matching.

Comprehensive Health Coverage: Medical, dental, vision, and life insurance options.

Wellness Focus: Access to programs designed to support your overall well-being.

Work–Life Balance: Paid time off and flexible work environment

Flexibility & Trust: A flexible schedule and work environment built around mutual trust and accountability.

Share the Talent, Share the Rewards: We value great people recommending great people, which is why our employee referral program is designed to reward you continuously

We offer a competitive salary and great benefits. At Excel Engineering, we’re proud of our positive, high-performing culture where teamwork, continuous improvement, and a service-oriented mindset help us do our best work every day. If you enjoy a fast-paced and rewarding environment, you’ll love being part of our team!

Excel Engineering, Inc. is proud to be an Equal Opportunity Employer.

We welcome and consider all qualified applicants without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, or any other protected characteristic.

We value diverse perspectives and believe they strengthen our work, our teams, and the solutions we deliver to clients. We encourage candidates from backgrounds traditionally underrepresented in engineering to apply.

If you need accommodations during the application or interview process, please contact our Human Resources team at [e-mail].