
Validation Engineer
CAI • Allentown, Pennsylvania, United States
Salary: $72,800 - $80,100 / year
**Role & Seniority: ** Commissioning & Qualification (CQV) / field documentation execution; early-career 2–4 years experience
**Stack/Tools: **
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ISPE Baseline Guide 5 (2nd Ed.) (preferred)
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CQV documentation artifacts: protocols, field verification, walk-downs, summary reports
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Client/industry compliance documentation workflows (regulated environments)
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Top 3 Responsibilities:
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Develop CQV documentation (including protocols)
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Write and execute field verification activities (protocol execution, field walk-downs)
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Produce on-site summary reports and support issue/troubleshooting at client locations
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Must-have Skills:
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CQV experience in a regulated industry (pharma/utilities/equipment focus)
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Ability to plan and coordinate work and direct small teams for document development/execution
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Strong technical documentation skills; clear professional communication with stakeholders
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Nice-to-haves:
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Experience with ISPE Baseline Guide 5 (2nd Ed.)
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Startups and troubleshooting; utilities (WFI, RO, HVAC)
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Upstream/downstream processing, purification/recovery
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Building automation; pharmaceutical manufacturing process experience
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Location & Work Type:
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Client site / field-based work for pharmaceutical facilities, utilities, and equipment (exact location not specified)
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**On-site commissioning/qualification and documentation e
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Full 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