Jobs · Quality Assurance · Indiana

Senior Validation Engineer

CAI · Indianapolis, IN · 2 wk ago
On-siteQuality AssuranceFull-time

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).

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