Validation Engineer
cagents
Indianapolis, Indiana
Posted Jan 11, 2021
- Full-time
- North America Life Sciences
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** **1. Technical Responsibilities** - Develop documentation for CQV activities - Write and execute protocols (field verification) - Develop summary reports at client sites **2. Areas of Focus** - Pharmaceutical facilities - Utilities - Equipment **3. 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