Validation Engineer

About the Company

CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. We serve mission-critical and regulated industries, delivering accelerated operational readiness and unparalleled performance in high-stakes environments through a rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our purpose is 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 are:

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

At CAI, we challenge ourselves to redefine industry standards through bold thinking, creativity, and relentless dedication to excellence. We operate at the intersection of wisdom and technology, thriving when they come together with humanity. Operational readiness is not just a goal—it’s a way of life.

Responsibilities

• Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
• Deliver C&Q activities in alignment with project schedules and track/report progress
• 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
• Support planning of commissioning spares and consumables
• Allocate project resources for efficient execution
• Coordinate support and logistics during CQV execution
• 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

Requirements

• Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
• 2+ 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 and a customer-focused mindset
• Willingness and flexibility to travel throughout the U.S. and potentially internationally

Skills

• 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