Csv Validation Engineer

6 days ago

Jaipur Pune, India Circulants Full time ₹ 7,00,000 - ₹ 12,00,000 per year

Key Role

  1. Develop, write, and maintain compliance and quality-related documents, including:

  2. Standard Operating Procedures (SOPs)

  3. Work Instructions (WIs)

  4. Validation Protocols (IQ/OQ/PQ)

  5. Risk Assessments

  6. Quality Manuals

  7. Audit Response Documentation

  8. Collaborate with QA, Regulatory, IT, and Project teams to gather inputs and ensure document accuracy and clarity.

  9. Translate complex technical and regulatory content into structured, user-friendly documentation.

  10. Ensure all content complies with applicable FDA, EMA, and ICH guidelines and client-specific quality frameworks.

  11. Assist in preparing documentation for client audits, internal assessments, and regulatory inspections.

  12. Maintain version control, change history, and document archiving using tools like SharePoint, Veeva Vault, or Documentum.

Contribute to the development of training materials and knowledge-sharing resources Role & responsibilities

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Preferred candidate profile

We are striclty looking for System Validation side not For Medical Devices, Equipments or Instruments validation side

Relevant Work Experience/Job Requirements:

  1. Hands-on experience in Computer System Validation (CSV) including preparation of VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports.

  2. Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines with exposure to regulatory audits.

  3. Experience with quality and compliance documentation including SOPs, change controls, deviations, and CAPA in a pharma environment.

  4. Practical knowledge of EDMS/QMS systems, LIMS, MES, and electronic signature platforms.

  5. Proven ability to collaborate with QA, IT, Manufacturing, and Regulatory teams for compliant system implementation and maintenance.

Must have Skill sets required:

  1. Computer System Validation (CSV) Expertise Hands-on in preparing and executing VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports.

  2. Regulatory & Compliance Knowledge Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.

  3. Quality Documentation & Audit Readiness Skilled in SOPs, change control, CAPA, deviations, and maintaining audit-ready records.

  4. Technical & System Knowledge Familiar with EDMS, QMS, LIMS, MES, and electronic signature platforms in regulated environments.

  5. Cross-functional Collaboration & Communication Ability to work closely with QA, IT, Manufacturing, and Regulatory Affairs teams.

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Other Skills:

  1. Risk Assessment & Impact Analysis Ability to perform risk-based validation and assess system changes for regulatory impact.

  2. Data Integrity & Audit Trail Review – Ensuring compliance with ALCOA+ principles and monitoring system audit trails.

  • CSV Validation Engineer

    1 week ago

    Pune, Maharashtra, India E Tech Group Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing &...

  • Csv Specialist

    4 weeks ago

    Jaipur, Rajasthan, India Adrta Technologies Private Limited Full time

    Job Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team.In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards.The ideal candidate will collaborate with cross-functional teams, contribute to audits and inspections,...

  • Cyber-CSV

    3 weeks ago

    Pune, India Talent Worx Full time

    We're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...

  • Cyber-CSV

    1 week ago

    Pune, India Talent Worx Full time

    We’re hiring for one of the world’s leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate...

  • Cyber-CSV

    2 weeks ago

    Pune, Maharashtra, India Talent Worx Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...

  • Cyber-CSV

    1 week ago

    Pune, India Talent Worx Full time

    We’re hiring for one of the world’s leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate...

  • Valuation Field Engineer

    2 weeks ago

    Indore, Jaipur, New Delhi, India CSV Techno Services Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role SummaryAs a Valuation Field Engineer at CSV Techno Services Pvt Ltd, you will be responsible for conducting property and asset valuations through a blend of office work and field/site visits. The role requires hands-on involvement in technical data collection, analysis, preparing detailed valuation reports, and liaising with clients and other teams.Key...

  • Tender Executive

    1 week ago

    Indore, Jaipur, New Delhi, India CSV Techno Services Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role SummaryThe Tender Executive will be responsible for end-to-end management of tenders, bids and proposals from opportunity identification and preparing technical and commercial proposals, to follow-ups, coordination with internal teams, submission, and post-submission clarifications. This role is pivotal in helping CSV Techno secure new projects,...

  • Computer System Validation Consultant/AM

    4 days ago

    Pune, Maharashtra, India Talworx Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesSupport on IT quality systems framework design and implementationManaging the reviews and assessments for IT qualityAssist in Computer System Validation (CSV) compliance of GxP processes forpharmaceutical companies or experience on quality compliance services for global consumerhealth care, medical devices, and pharmaceutical...

  • DigiHelic Solutions

    3 weeks ago

    Pune, India Digihelic Solutions Private Limited Full time

    Work youll do. As a part of our Technology & Transformation team, Youll : - Support on IT quality systems framework design and implementation. - Managing the reviews and assessments for IT quality. - Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global...