Full-Time

Senior Validation Engineer

CAI

CAI

501-1,000 employees

Operational readiness consulting for pharma

Compensation Overview

$87.1k - $120.2k/yr

Raleigh, NC, USA

In Person

Category
QA & Testing (2)
,
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
  • Customer-focused mindset
  • Willingness and flexibility to travel throughout the U.S. and potentially internationally
Responsibilities
  • 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
  • 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
  • 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
Desired Qualifications
  • 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

CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.

Company Size

501-1,000

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Simplify Jobs

Simplify's Take

What believers are saying

  • JLL Partners investment expands CAI globally across four continents for 700 professionals.
  • Fedegari partnership integrates turnkey sterilization, cutting biotech lifecycle costs.
  • CAI's CQV services marked 30 years in 2026, accelerating facility compliance worldwide.

What critics are saying

  • Oracle Life Sciences automates CQV with cloud platforms, eroding CAI's share in 12 months.
  • Fedegari sells sterilization systems directly, capturing pharma clients in 18 months.
  • JLL-mandated expansion dilutes CAI expertise, causing CQV failures in 24 months.

What makes CAI unique

  • CAI specializes in commissioning, qualification, and validation for life sciences facilities.
  • CAI delivers operational readiness assessments for biotech and pharma full-scale production.
  • CAI pioneered neurodiversity hiring in enterprise consulting services.

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Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country