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Validation Engineer

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About CAI:

CAI was established in 1996; it has grown year over year to more than 750 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Are you ready?

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

• We act with integrity

• We serve each other

• We serve society

• We work for our future.

We strongly believe that one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

Requirements Include

Led end-to-end CQV and CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ execution, and final reporting for GMP-regulated environments.

Executed risk-based validation strategies compliant with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

Managed Commissioning of Plant Utilities, Commissioning and qualification of clean utilities, process equipment, HVAC systems, Automation and computerized systems for Biotech API and Fill Finish facilities.

Experienced in commissioning, qualification, and validation of Water Systems (PW/WFI), CIP/SIP systems, autoclaves, bioreactors, nitrogen and process air systems.

Demonstrated knowledge of upstream and downstream manufacturing equipment qualification, supporting GMP-compliant project execution throughout the equipment and utility lifecycle.

Developed and reviewed validation documentation including VMPs, SOPs, RTMs, protocols, and summary reports.

Performed FAT, SAT, commissioning, and shakedown testing ensuring seamless transition into qualification phases.

Utilized platforms like Kneat / Veeva / TrackWise for electronic validation lifecycle management.

Conducted GxP impact assessments, data integrity risk assessments, and FMEA analyses to define validation scope.

Collaborated cross-functionally with QA, Engineering, IT, and Vendors to deliver projects on schedule.

Managed deviations, CAPA, and change controls ensuring audit-ready documentation at all stages.

Mentored junior engineers on CQV/CSV best practices and regulatory expectations.

1. Deviation handling
2. IQ/OQ/PQ execution
3. Audit findings and responses

Knowledge on Regulatory frameworks (FDA, ICH, EU, MHRA, GAMP 5, ISPE, ASME BPE)

Position Requirements
A bachelor’s degree or master's degree in chemical engineering, Biotech Engineering, Mechanical Engineering, Chemistry or Life Sciences, in the Pharmaceutical/Life Sciences industry. Engineering Consultancy (for Biopharma).

Core Focus Areas:

Commissioning, Qualification & Validation (CQV)

Regulatory compliance (FDA, ICH, GAMP 5)

Commissioning of Plant Utilities and Integration and Handshake with other systems, Clean Utilities, HVAC (CIP, SIP, WFI system, Part Washer and HVAC system and manufacturing process equip)

Equipment & system qualification (HVAC, Clean Utilities, manufacturing Process systems)

Documentation, execution, and lifecycle validation

Key Responsibilities:

Develop and execute CQV/CSV validation strategies

Prepare and review IQ, OQ, PQ protocols and reports

Perform risk assessments (FMEA, GxP, data integrity)

Support design reviews, FAT/SAT, commissioning activities

Collaborate with Project, QA, Engineering, Manufacturing, IT, System Vendors

Maintain audit-ready documentation

Use tools like Kneat, Veeva, TrackWise

Ensure compliance with:

1. FDA 21 CFR Part 11
2. EU Annex 11
3. ICH Q8/Q9/Q10
4. GAMP 5
5. ISPE Guideline

Lead/mentor junior team members

Manage timelines, stakeholders, and project execution

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture 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.
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What this application asks

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Resume/CV, Full name, Pronouns, Email, Phone, Current location, Current company, LinkedIn URL, Twitter URL, GitHub URL, Portfolio URL, Glassdoor URL, What is your age range?, I identify my ethnicity asSelect all that apply, What gender do you identify as?, Are you a U.S. Military Veteran

  • What is your salary expectation? (Please provide a numeric value, a range is acceptable) written answer
  • Please provide earliest commencement date for this role?
  • How many years of relevant work experience do you have? choose one
  • Do you have minimum 5 to 10 years experience in validation activities for Commissioning & Qualification of Bio Pharmaceutical facilities written answer · optional
  • Do you have working experience in India? written answer · optional
  • Do you have experience working in Multinational Pharma related Organisation/s? written answer · optional
  • Are you willing to travel for commissioning & qualification activities? written answer · optional
  • Do you have hands-on experience for Commissioning, Qualification, and Validation (CQV) activities for GMP-regulated pharmaceutical or biotechnology facilities? written answer · optional
  • Do you have experience commissioning of black utilities and qualifying clean utilities and process equipment for upstream / downstream manufacturing such as PW/WFI systems, CIP/SIP systems, HVAC, autoclaves, bioreactors, compressed gases, or process air systems? written answer · optional
  • Have you independently performed risk assessments (e.g., FMEA, GxP Impact Assessments, Data Integrity Assessments) and applied risk-based validation methodologies? written answer · optional
  • Do you have experience preparing and/or reviewing qualification and validation documentation, including URS, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, Validation Plans, and Summary Reports? written answer · optional
  • Do you have experience executing Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 requirements? written answer · optional
  • Why are you seeking a new position? written answer
  • What is your notice period? optional
  • What is your salary expectation? (Please provide a numeric value in INR, a range is acceptable) written answer
  • If referred by a CAI employee, please provide their name(s) optional

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