Validation Engineer

CAI

Cleveland (OH)

On-site

USD 70,000 - 110,000

Full time

5 days ago

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Benefits offered by this job

Comprehensive Health Insurance

24 days of Paid Time Off

Company paid Life Insurance

Company paid Long Term Disability

Job summary

CAI is seeking a CQV-focused engineer to develop documentation for commissioning and qualification activities at client sites in the pharmaceutical sector. You will write and execute field verification protocols, create client-ready summary reports, and plan cross-functional work streams.

The role requires coordinating small teams, ensuring compliance with ISPE Baseline Guide 5 guidance, and supporting utilities, equipment start-ups, and validation activities across GMP facilities.

Qualifications

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

Responsibilities

Develop documentation for CQV activities
Write and execute protocols (field verification)
Develop summary reports at client sites
Plan and coordinate work
Direct small teams in document development and/or execution

Skills

Regulated industry experience

Commissioning & qualification

ISPE Baseline Guide 5

Education

Bachelor’s degree in science or engineering

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.

Are You Ready?

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

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.

CAI Benefits