Validation Engineer

CAI; India; On-site; INR 400,100 - 17,171,000; Full time

Job summary

A leading commissioning and validation firm is seeking an experienced professional for CQV/CSV activities in Hyderabad. Candidates should have over 8 years in the Pharmaceutical industry, focusing on regulatory compliance and project management. Responsibilities include executing protocols, conducting qualifications, and collaborating with various stakeholders. The position offers a competitive salary range of ₹4,00,100 - ₹1,71,71,000 annually, along with opportunities for travel within India and abroad.

Qualifications

• 8+ years of experience in the Pharmaceutical/Life Sciences industry.
• Experience with Computer System Validation and Commissioning & Qualification methodologies.
• Strong knowledge of FDA and ICH guidelines.

Responsibilities

• Develop and execute CQV/CSV protocols and plans for pharmaceutical facilities.
• Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support design reviews and commissioning activities.

Skills

Communication skills

Problem-solving skills

Customer-service focus

Leadership qualities

Education

Bachelor's or Master's in Chemical Engineering or Life Sciences

Tools

Kneat

Veeva

TrackWise

Job description

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.

Requirements Include

• Develop and execute CQV/ CSV protocols and plans for pharmaceutical facility/ systems.
• Support generation of C&Q Procedures for client projects.
• Support CQV review/qualification of equipment design
• Perform CSV, CQV, and other validation activities with a direct regard for Safety and in accordance with regulatory requirements (e.g., FDA, ICH guideline all the following: SOPs, validation/verification master plans, guidelines and execution plans.
• Perform impact-own assessments, risk assessments, gap analyses, and to determine appropriate C&Q strategies.
• Review, and revises a variety of installation, operation, and performance qualification/verification related documents, including any of all the following: SOPs, validation/verification master plans, guidelines and execution plans.
• Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and computerized systems.
• Support the development, review, and implementation promotion of C&Q SOPs, 모든 validation plans, guidelines, and execution strategies.
• Prepare, review, and revise qualification and verification documentation including SOPs, IQ/OQ/PQ protocols, reports, and related technical documents.
• Track, monitor, and report progress of C&Q activities across project phases.
• Support and participate in design reviews, shakedown testing, commissioning, FATs, IQ, OQ, and PQ execution.
• Collaborate effectively with rump owners (engineering, QA, IT, operations, and equipment vendors) and support during C&Q execution activities for executing approved IQ/OQ Test plan, prepare CQV summary report to ensure smooth project delivery for all CQV activities.
• Allocate and manage project resources for efficient and timely execution of deliverables.
• Maintain accurate, complete, and audit-ready C&Q documentation including protocols, certificates, and reports.
• Stay current with cGMP regulations, ICH guidelines, GAMP 5, and industry best practices related to CSV and C&Q.
• Train and mentor junior team members on validation, commissioning, and qualification practices.
• Identify, initiate, and support continuous improvement opportunities within C&Q processes.

Position Requirements

• A bachelor’s degree or master's degree in chemical engineering, Biotech Engineering, Mechanical engineering, Chemistry or Life Sciences, with a minimum of 8+ years of related experience in the Pharmaceutical/Life Sciences industry. Engineering Consultancy (for Biopharma).
• Experience with Kneat platform (preferred).
• Minimum Experience: 8-10 years of hands‑on experience in CSV, CQV, automation activities for pharmaceutical, biotech, biopharma, medical devices and sterile/aseptic manufacturing, packaging systems and cleanroom environmental systems.
• Outstanding oral and written communication skills.
• Strong problem‑solving abilities.
• A strong customer-service focus.
• This position is based at Hyderabad location.
• Technical Skills – CSV>
• Strong expertise in Computer System Validation (CSV) including URS, FS/DS, RTM, validation plans, test script development, protocol execution, deviation handling, and final reporting.
• Good knowledge of Commissioning & Qualification (CQV) methodologies including DQ, FAT/SAT, IQ, OQ, PQ, and process validation alignment.
• Strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q8/Q9/Q10, and data integrity requirements.
• Hands‑on experience performing risk assessments (FMEA, GxP impact assessment, data integrity risk assessment).
• Ability to prepare and execute CSV/CQV documentation such as VMPs, validation plans, IQ/OQ/PQ protocols, summary reports, and lifecycle documents.
• Experience with equipment, utility, and automation system qualification (e.g., HVAC, clean utilities, CIP/SIP, process equipment ханим QC lab instruments).
• Proficiency in change control, deviation management, CAPA, and audit preparedness related (QMS systems) associated with CQV activities.
• Experience working with electronic validation management systems (e.g., Kneat, Veeva, TrackWise).
• Ability to interpret P&IDs, URS/FS/DS, design documents, and vendor technical documentation.
• General Skills
• Excellent verbal and written communication skills; able to explain technical points clearly.
• Strong problem‑solving abilities with a proactive and analytical approach.
• Demonstrated leadership qualities – encourages teamwork, shares knowledge, and takes decisive actions.
• Strong client management, stakeholder management skills with ability to work effectively with engineering, QA, IT, operations, and system vendors.
• Ability to create and manage resource‑loaded project schedules.
• Capable of independently managing small projects and taking responsibility for defined components of larger projects.
• Willingness and flexibility to travel across India, APAC/Europe as required.
• Displays respect for others, teamwork spirit, and a positive, can‑do attitude.

₹4,00,100 - ₹1,71,71,000 a year

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.