Job Title: Equipment Validation Engineer
Summary:
- Responsible for the planning, execution, and documentation of equipment qualification and validation activities within a GMP-regulated pharmaceutical manufacturing environment.
- Ensures that all equipment meets regulatory requirements and company quality standards.
Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ).
- Generate and maintain accurate validation documentation.
- Perform risk assessments related to equipment validation.
- Coordinate with cross-functional teams (QA, manufacturing, engineering).
- Ensure compliance with GMP and relevant regulatory guidelines.
- Troubleshoot and resolve validation deviations.
- Manage equipment calibration and maintenance related to validation.
- Review and approve validation related documentation.
Qualifications:
- Bachelor’s degree in Engineering or a related science field.
- Experience in equipment qualification and validation in a GMP environment.
- Strong understanding of GMP regulations and industry standards.
- Excellent documentation and communication skills.