Senior Validation Consultant

2 days ago

Shimoga, Karnataka, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title: Senior Validation Trainer

We are seeking a highly experienced professional to join our team in the role of Senior Validation Trainer. As a key member of our global CQV projects, you will be responsible for supporting the preparation, execution, and lifecycle management of validation documentation for new and existing facilities, utilities, systems, and equipment.

The ideal candidate will have over 10 years of hands-on experience in Commissioning, Qualification, and Validation activities across the pharmaceutical and medical device sectors. You will possess a deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10, ISO 13485) and expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.

A Bachelor's or Master's degree in Engineering, Life Sciences, or a related field is required. You will also need to be proficient in using validation lifecycle software and document management systems. Excellent communication and technical writing skills are essential for this role.

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:

This is an excellent opportunity to work in a dynamic and growing organization with a strong commitment to quality and customer satisfaction. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter, to [contact email]. We look forward to hearing from you

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