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Validation Engineer

CAI Harrisburg, Pennsylvania, United States

onsitefull-time

Salary: $72,800 - $80,100 / year

Posted Aug 7, 2026Apply by Sep 6, 2026
  • Role & seniority

    • Commissioning & Qualification (CQV) / Validation support (junior–mid level)

    • Experience level: ~2–4 years in commissioning/qualification in a regulated industry

  • Stack / tools

    • ISPE Baseline Guide 5 (2nd ed.) familiarity (plus)

    • CQV documentation tooling (not specified); field verification / walk-downs

    • Client-site execution and reporting (templates/protocols)

  • Top 3 responsibilities

    • Develop CQV documentation and write protocols for field verification

    • Execute field verification activities and perform protocol-based checks

    • Produce summary reports at client sites; support troubleshooting/turnover

  • Must-have skills

    • Strong CQV/commissioning & qualification experience in regulated environments

    • Ability to write protocols and documentation (clear, compliant technical writing)

    • Competence performing field verification/walk-downs and documenting outcomes

    • Effective communication with clients and project stakeholders

  • Nice-to-haves

    • Familiarity with ISPE Baseline Guide 5 (2nd ed.)

    • Experience with pharma startup, purification/recovery, and upstream/downstream

    • Utilities experience: WFI, RO, HVAC

    • Building automation experience

    • Participation in equipment/facility startup, walk-downs, troubleshooting

    • Potential project/team support: plan/coordinate work; direct small teams

  • Location & work type

    • **Not specifie

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

Commissioning and QualificationCQV DocumentationProtocol ExecutionField VerificationPharmaceutical ManufacturingUtilities ValidationTroubleshootingBuilding AutomationUpstream ProcessingDownstream ProcessingPurificationRecoveryProject ManagementTeam LeadershipTechnical CommunicationStakeholder Managementmulti-location

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