Validation Engineer

 

 

 

•                 We act with integrity

•                 We serve each other

•                 We serve society

•                 We work for our future.

 

•                 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 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 of C&Q SOPs, validation master 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 all the stakeholders (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.

•                 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 activitiesfor 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/CQV

•                 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, 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.

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.