Description:
The Equipment Validation Engineer is responsible for ensuring that pharmaceutical manufacturing equipment and systems are compliant with regulatory standards, operational requirements, and company policies. This role involves leading and executing equipment qualification, validation, and requalification activities in accordance with Good Manufacturing Practices (GMP), FDA regulations, and internal standard operating procedures (SOPs).
Key Responsibilities:
- Lead and execute the qualification of new and existing equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Perform and document validation activities for equipment, including autoclaves, lyophilizers, mixers, pumps, filtration units, etc.
- Review and approve qualification/validation documentation, ensuring compliance with regulatory and company standards.
- Ensure all validation activities are performed in compliance with GMP, FDA, EMA, and other relevant regulations.
- Prepare and submit validation documentation for regulatory inspections and audits.
- Support internal and external audits related to equipment qualification/validation activities.
- Identify and troubleshoot equipment-related issues during qualification or routine operations.
- Conduct root cause analysis of equipment failures and implement corrective and preventive actions (CAPA).
- Develop and execute detailed validation plans and schedules.
- Prepare and review validation documentation, including test scripts, protocols, reports, and deviations.
- Maintain accurate and timely documentation for validation activities and equipment lifecycle management.
- Work closely with cross-functional teams (Engineering, Manufacturing, Quality Assurance, etc.) to ensure equipment is validated and operational.
- Provide technical support to other departments regarding equipment operations and validation procedures.
- Participate in continuous improvement initiatives to streamline validation processes and ensure the efficiency of equipment validation activities.
- Recommend and implement improvements for equipment and systems to enhance performance and compliance.
Requirements:
- Education:
- Bachelor’s degree in Engineering, Pharmacy, Life Sciences, or related field.
- Experience:
- 3 to 5 years of experience in equipment validation within the pharmaceutical or biotechnology industry.
- Strong understanding of GMP, FDA, and other regulatory requirements related to pharmaceutical manufacturing.
- Skills:
- Hands-on experience with qualification and validation of pharmaceutical equipment.
- Knowledge of qualification/validation protocols (IQ, OQ, PQ).
- Familiarity with software systems (e.g., SAP, TrackWise) for documentation and change control.
- Strong problem-solving, analytical, and troubleshooting skills.
- Excellent written and verbal communication skills.