Senior Validation Professional

8 hours ago

Ajmer, Rajasthan, India beBeeValidation Full time ₹ 1,60,00,000 - ₹ 2,40,00,000

We are seeking a highly experienced professional to support global Commissioning, Qualification, and Validation (CQV) projects remotely.

This role involves preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:

  • Lead and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation including User Requirements Specification (URS), Design Qualification (DQ), Functional Performance Qualification (FAT), System Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and risk assessments.
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with Good Automated Manufacturing Practice (GAMP) 5, FDA, European Medicines Agency (EMA), and ISO 13485 requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
  • Mentor junior CQV professionals and act as a subject matter expert (SME) in audits and inspections.

Required Skills and Qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on CQV experience in the pharmaceutical and/or medical device industries.
  • Deep understanding of regulatory requirements.
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.
  • Proficient in using validation lifecycle software and document management systems.
  • Excellent communication and technical writing skills.

Preferred Skills and Qualifications:

  • Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products.
  • CQV experience in greenfield or brownfield capital projects.
  • Knowledge of Agile, Lean Six Sigma, or project management certifications.
  • Prior experience working with global, cross-cultural teams remotely.

Tools and Platforms:

  • Veeva Vault, ValGenesis, TrackWise, Kneat Gx.
  • Microsoft Office Suite, MS Project, SharePoint.
  • Remote collaboration tools (MS Teams, Zoom, Slack).

  • Senior Validation Strategist

    1 hour ago

    Ajmer, Rajasthan, India beBeevalidation Full time ₹ 15,00,000 - ₹ 25,00,000

    We are seeking a skilled Validation Strategist to drive our validation efforts. This is an exciting opportunity for a seasoned professional to lead the development and implementation of validation strategies and processes.">The ideal candidate will have a strong background in validation, with experience in developing and implementing validation plans,...

  • Highly Skilled Senior Data Validator Wanted

    10 hours ago

    Ajmer, Rajasthan, India beBeeDataValidator Full time ₹ 1,50,000 - ₹ 3,00,000

    Senior Data Validator PositionAt our organization, we are seeking a highly skilled Senior Data Validator to support our critical data migration initiative. This role is an exciting opportunity for a motivated and detail-oriented professional.About the RoleThis Senior Data Validator will be responsible for executing thorough testing of ETL pipelines and data...

  • Validation Lead

    8 hours ago

    Ajmer, Rajasthan, India Compliance Group Inc Full time

    We are looking for Validation Lead for Compliance Group Inc.High preference to short notice period.Experience : 6 to 12 yearsLocation: Hyderabad (Remote)Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.Collaborate with cross-functional teams including development,...

  • Senior Validation Specialist

    9 hours ago

    Ajmer, Rajasthan, India beBeeValidation Full time ₹ 12,00,000 - ₹ 24,91,000

    Job Summary:We are seeking a skilled Senior Validation Specialist to join our team. In this role, you will be responsible for ensuring the quality and compliance of computer systems in a regulated industry.About the Role:The ideal candidate will have a Bachelor's degree in a related field and 5-8 years of experience in validation and quality compliance. You...

  • Post Silicon Validation Expert

    15 hours ago

    Ajmer, Rajasthan, India beBeeFpga Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job DescriptionA senior engineer role in silicon validation is now available at our company.Key responsibilities include system-level testing, debugging interfaces and design-level debugging, as well as board-level debugging.We are looking for a candidate with strong knowledge of RTL design and implementation, expertise in FPGA design flow and validation,...

  • Computer Systems Validation Specialist

    4 days ago

    Ajmer, Rajasthan, India beBeeValidation Full time ₹ 20,00,000 - ₹ 40,00,000

    Job DescriptionWe are seeking a seasoned professional to spearhead computer system validation strategies and ensure regulatory compliance across our operations.As a key member of our team, you will be responsible for developing and executing comprehensive validation plans, collaborating with cross-functional teams, and providing technical expertise to...

  • Senior Audit Professional

    4 days ago

    Ajmer, Rajasthan, India beBeeAudit Full time US$ 80,000 - US$ 1,20,000

    Job Title: Senior Audit ProfessionalAbout the Role:We are seeking a skilled Senior Associate to join our audit team as a critical member, playing a key role in the execution of audits and collaborating with talented professionals.Key Responsibilities:Engagement Execution: Plan, execute, and monitor audit engagements to ensure timely completion of...

  • Senior Accounting Professional

    15 hours ago

    Ajmer, Rajasthan, India beBeeAccounting Full time ₹ 8,00,000 - ₹ 10,00,000

    Job Title: Senior Accounting ProfessionalWe are seeking a highly skilled and experienced Senior Accounting Professional to join our team. As a key member of our finance department, you will be responsible for managing all accounting functions, including financial reporting, budgeting, and forecasting.Key Responsibilities:Manage all aspects of financial...

  • Senior Data Validator

    5 days ago

    Ajmer, Rajasthan, India beBeeOblm Full time ₹ 9,00,000 - ₹ 12,00,000

    We are seeking a professional to fill a Tester position.Key Responsibilities:Mandatory - Knowledge of MT103 + MT202 ( SWIFT Payments)Requirements:Bachelor's DegreeAt least 4+ years of relevant working experiencesStrong communication skills and interpersonal skillsProficiency in MS Office (Word, Excel)Knowledge on OBLM productAttentive to details, strong...

  • Senior Tax Professional

    2 days ago

    Ajmer, Rajasthan, India beBeeTax Full time ₹ 20,00,000 - ₹ 25,00,000

    Job OpportunityWe are seeking a highly skilled Senior Tax Research Analyst to join our team.This role combines academic rigor with practical relevance, requiring someone who can analyze, interpret, and present complex tax legislation and concepts in a clear, authoritative, and engaging manner.The Senior Tax Research Analyst will play a pivotal role in...