Senior Validation Engineer

CAI; Greenville (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

CAI in North Carolina seeks a CQV Engineer to lead commissioning, qualification, and validation activities in pharmaceutical projects, with a focus on safety and regulatory compliance.

You will coordinate testing with contractors, review CQV procedures, and help plan spares and resources across the project lifecycle. Willingness to travel within the U.S. required. CAI emphasizes integrity, teamwork and delivering critical solutions for regulated industries.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may substitute for education.
• 3+ years in Pharmaceutical/Life Sciences.
• Experience in GMP environment.
• Strong written and oral communication.
• Willingness to travel across the U.S. and possibly internationally.

Responsibilities

• Perform CQV (Commissioning, Qualification, Validation) activities with a focus on safety.
• Deliver CQV tasks aligned to project schedules and document progress.
• Support creation and review of CQV procedures and qualification documents.
• Coordinate testing with project contractors and equipment vendors.
• Plan commissioning spares, consumables, and allocate resources.
• Assist with CQV reviews and qualification of equipment design.

Skills

Excellent communication

Problem solving

Customer-focused

Willingness to travel

Education

Bachelor’s degree in Engineering, Chemistry, or Life Sciences

Job description

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

Our Foundational Principles:

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity.

For us, operational readiness isn’t simply a goal—it’s a way of life. Tomorrow demands to be at the forefront of today. We get there through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Key Responsibilities

CQV Execution & Safety

• Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
• Deliver C&Q activities in alignment with project schedules
• Track and report progress of CQV efforts

Documentation & Compliance

• Support the generation and review of C&Q procedures for client projects
• Review and revise qualification-related documents, including SOPs, master plans, and execution plans
• Assist with CQV review and qualification of equipment design

Project Planning & Coordination

• Support planning of commissioning spares and consumables
• Allocate project resources for efficient execution
• Coordinate support and logistics during CQV execution

Testing & Vendor Management

• Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
• Coordinate with project contractors and equipment vendors to execute required testing

Qualifications And Experience

• Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
• 3+ years of related experience in the Pharmaceutical/Life Sciences industry
• Essential experience in a GMP (Good Manufacturing Practice) environment
• Outstanding oral and written communication skills
• Strong problem-solving abilities
• Customer-focused mindset
• Willingness and flexibility to travel throughout the U.S. and potentially internationally

Critical Competencies

Influence Strategy

• Evaluates and pursues opportunities based on organizational strategy
• Identifies innovative solutions with strategic impact
• Anticipates emerging customer and market needs

Satisfy the Customer

• Understands and anticipates client needs
• Develops solutions that exceed expectations
• Actively follows up to ensure satisfaction and loyalty

Plan for Success

• Aligns business strategies with actionable plans
• Allocates resources effectively
• Anticipates risks and builds contingency plans

Pursue Execution

• Prioritizes initiatives to ensure goal achievement
• Holds self and team accountable
• Proactively removes obstacles

Tailor Communication

• Communicates clearly, concisely, and professionally
• Adjusts messaging to suit audience
• Explains technical concepts across all levels

Build Partnerships

• Builds strong networks across teams and disciplines
• Promotes collaboration and removes silos
• Involves stakeholders in decision-making

Influence Others

• Builds support through sound reasoning
• Gains buy-in from decision makers
• Encourages innovation and better outcomes

Develop Self And Others

• Continuously develops relationship and leadership skills
• Acts with integrity and models company values
• Seeks out breakthrough opportunities

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.