Commissioning Specialist

1 day ago

Hyderabad, Telangana, India beBeeValidation Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
**Senior CQV Engineer Trainer Role**This position involves supporting global Commissioning, Qualification, and Validation (CQV) projects remotely. As a Senior CQV Engineer Trainer, you will ensure compliance with FDA, EU, and other international regulations.
Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams (engineering, QA, manufacturing, IT) 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 GAMP 5, FDA, EMA, and ISO 13485 (for medical devices) 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 engineers 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 pharma and/or medical device industries.
  • Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10, ISO 13485).
  • 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.
Benefits:You will have the opportunity to work on complex CQV projects and contribute to the development of new processes and procedures. Our team values collaboration, innovation, and continuous learning.Others:We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced CQV professional looking to take on new challenges, please apply.

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