Validation Engineer - Pharmaceutical Manufacturing

Excel Engineering•Mounds View, MN

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in chemical, biomedical, mechanical, computer, electrical, or another relevant engineering or scientific discipline.
5-15 years of validation, commissioning, qualification, or related engineering experience in pharmaceutical or medical device manufacturing.

Nice To Haves

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%.

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.