Highly Experienced Validation Expert

5 days ago

Varanasi, Uttar Pradesh, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title:

Senior Validation Engineer

Overview:

We seek a highly experienced professional to lead and execute validation activities across the pharmaceutical and medical device sectors.

The ideal candidate will support global projects remotely, ensuring compliance with FDA, EU, and other international regulations.

Responsibilities:
  • Lead and execute validation activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory standards.
  • Develop and review validation documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless 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 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.
Requirements:

Minimum 10 years of experience in Commissioning, Qualification, and Validation activities.

Proven expertise in leading cross-functional teams and collaborating with stakeholders.

Excellent communication and project management skills.

Benefits:

This is an excellent opportunity to work on high-profile projects and develop your career as a senior validation engineer.

Our team provides a collaborative and supportive environment that encourages professional growth and development.

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