Validation Engineer

Cagents · Indianapolis, Indiana · 2-4 years · Full Time

Key skills

  • Software Engineering
  • Problem Solving
  • System Design

Job description

Are You Ready?

CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential 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 Purpose

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

  • At CAI, we are committed to living our values - both professionally and personally:
  • We act with integrity
  • We serve each other
  • We serve society
  • We work for our future
  • We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity - always focused on how it will be done, not how it used to be done.

Key Responsibilities

  • Technical Responsibilities
  • Develop documentation for CQV activities
  • Write and execute protocols (field verification)
  • Develop summary reports at client sites
  • Areas of Focus
  • Pharmaceutical facilities
  • Utilities
  • Equipment
  • Project & Team Management
  • Plan and coordinate work
  • Direct small teams in document development and/or execution

Qualifications and Experience

  • Bachelor's degree in a science or engineering field (or equivalent experience)
  • 2 - 4 years' experience in commissioning and qualification in a regulated industry
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
  • Preferred experience in:
  • Facilities and equipment startup
  • Walk-downs and troubleshooting
  • Utilities (WFI, RO, HVAC)
  • Upstream/downstream processing
  • Purification, recovery
  • Building automation
  • Pharmaceutical manufacturing processes

Critical Competencies

Influence Strategy

  • Pursues initiatives aligned with organizational strategy
  • Identifies strategic, innovative solutions
  • Anticipates emerging customer/market needs

Satisfy the Customer

  • Understands and anticipates customer needs
  • Delivers high-quality solutions and service
  • Proactively maintains satisfaction and loyalty

Plan for Success

  • Aligns business strategies with actionable plans
  • Anticipates risks and builds contingency plans
  • Secures resources for goal achievement

Pursue Execution

  • Prioritizes time and resources effectively
  • Holds self and others accountable
  • Acts to overcome obstacles and improve quality

Tailor Communication

  • Communicates clearly and professionally
  • Adjusts style to fit the audience
  • Explains technical concepts effectively

Build Partnerships

  • Builds networks across functions
  • Encourages collaboration and breaks down silos
  • Involves stakeholders in decisions

Influence Others

  • Builds support with sound rationale
  • Gains buy-in from decision makers
  • Encourages innovative thinking

Develop Self and Others

  • Enhances interpersonal relationships
  • Models integrity and company values
  • Seeks out growth and breakthrough opportunities

#LI-MV1

Apply on the official Cagents careers page

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