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Senior Validation Engineer
Senior Validation EngineerCagents • Raleigh, NC, US
Senior Validation Engineer

Senior Validation Engineer

Cagents • Raleigh, NC, US
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Raleigh, North Carolina / Southeast / Full Time

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
  • 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
  • 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

  • Anticipates risks and builds contingency plans
  • Pursue Execution

    • Prioritizes initiatives to ensure goal achievement

  • Holds self and team accountable
  • Proactively removes obstacles
  • 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
  • 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

    • 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

    • J-18808-Ljbffr

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    Validation Engineer • Raleigh, NC, US