Validation Engineer bei CAI
CAI · Indien · Hybrid
- Optionales Büro in
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
• 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.
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 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.
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