Validation Specialist

Position Overview

We are seeking a meticulous and technically proficient Validation Specialist to join our team, ensuring that our facilities, utilities, equipment, computerized systems, and manufacturing processes remain in a validated state through structured qualification and validation activities. In this critical role, you will be responsible for maintaining compliance with current Good Manufacturing Practices (cGMP), data integrity standards, and global regulatory guidelines, including EU GMP, WHO GMP, FDA regulations, and GAMP 5. Your expertise will be instrumental in preparing comprehensive validation documentation, executing qualification protocols, and coordinating cross-functional validation initiatives to uphold the highest standards of quality and regulatory adherence.

Key Responsibilities

The Validation Specialist will play a pivotal role in the following areas:

• Validation & Qualification Activities:
  • Develop, review, and approve validation protocols, test scripts, data sheets, and validation reports in accordance with regulatory requirements and internal standards.
  • Plan and execute qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and computerized systems.
  • Conduct process, cleaning, and computerized system validation in alignment with approved protocols and regulatory expectations.
  • Ensure all validation and revalidation activities are conducted in accordance with the Validation Master Plan (VMP) to maintain compliance and operational integrity.
  • Uphold the validated state of systems through periodic reviews, change control management, deviation handling, and Corrective and Preventive Action (CAPA) support.
• Documentation & Compliance:
  • Review, update, and maintain Standard Operating Procedures (SOPs) related to validation activities to ensure alignment with current regulations and best practices.
  • Prepare, maintain, and archive master validation files and technical documentation, ensuring accuracy, completeness, and accessibility.
  • Evaluate calibration, preventive maintenance, and maintenance records to assess their impact on validated systems and overall compliance.
  • Ensure adherence to cGMP, data integrity principles, and company SOPs throughout all validation activities.
  • Support regulatory inspections by providing comprehensive validation documentation, technical explanations, and evidence of compliance.
• Quality Systems Management:
  • Initiate, assess, and support change control, deviation management, and CAPA processes related to validated systems to address and prevent quality issues.
  • Analyze environmental monitoring data and critical process parameters from a validation perspective to identify trends and potential risks.
  • Ensure proper documentation practices and strict adherence to validation procedures to maintain regulatory compliance and operational excellence.
• Collaboration & Training:
  • Coordinate validation activities with cross-functional teams, including Production, Quality Control (QC), Engineering, Information Technology (IT), Warehouse, and external vendors to ensure seamless execution and alignment with business objectives.
  • Provide support for installation, qualification, calibration, and maintenance activities to ensure systems remain in a validated state.
  • Collaborate with QC to ensure alignment on analytical methods and laboratory validation requirements, fostering a culture of quality and compliance.
  • Oversee outsourced validation activities, including those conducted by contract laboratories and service providers, to ensure consistency and compliance with internal and regulatory standards.

Qualifications & Skills

• Education: Bachelor’s degree in Pharmacy, Engineering, Life Sciences, or a related field.
• Experience: Minimum of 2–5 years of hands-on experience in pharmaceutical validation or the qualification of equipment and systems.
• Technical Skills:
  • In-depth knowledge of the validation lifecycle, including DQ, IQ, OQ, and PQ phases, as well as risk-based validation methodologies.
  • Proven experience in equipment, utility, process, cleaning, and computerized system validation.
  • Strong understanding of maintaining the validated state through periodic reviews, change control, deviation handling, and CAPA support.
• Regulatory Knowledge: Comprehensive understanding of EU GMP, WHO GMP, FDA 21 CFR 210/211, 21 CFR Part 11, and GAMP 5 guidelines.