Senior 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 through a rigorous, field-tested approach and elite expertise developed over 30 years. Our purpose is to be the trusted solution for clients as they 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 challenge ourselves to redefine industry standards through bold thinking, creativity, and a 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 CQV 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)
- 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 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
Benefits
- Comprehensive Health Insurance coverage
- 24 days of Paid Time Off
- Company-paid Life Insurance
- Company-paid Long Term Disability
Average base salary range (not including benefits, potential overtime, or Cost of Living Adjustment).