Validation Engineer

CAI; Allentown (Lehigh County); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off (24 days)

Life Insurance

Long Term Disability

Job summary

CAI is seeking a CQV professional with 2–4 years in commissioning and qualification for regulated industries. You will develop CQV documentation, write and execute field verification protocols, and create summary reports at client sites, supporting pharmaceutical facilities, utilities, and equipment projects.

The role emphasizes project and team management, planning, and directing small teams in document development and execution, with a focus on quality and regulatory compliance.

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 utilities.

Responsibilities

• Develop documentation for CQV activities.
• Write and execute protocols (field verification).
• Develop summary reports at client sites.

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.

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:

• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability