Validation Engineer Pharmaceutical Manufacturing

Full-time

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 weve 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

• Bachelors 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.

WorkLife 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 were 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 youll 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

Salary Description

$105000 - $140000 per year

Required Experience:

IC