Job Description:
The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems used in manufacturing are validated maintained and compliant with regulatory requirements. This role supports manufacturing operations by providing documented evidence that systems perform as intended ensuring product quality and regulatory compliance.
Responsibilities:
- Perform equipment validation and requalification to ensure systems remain in a validated state.
- Maintain and organize validation tools such as dataloggers and probes.
- Validate biopharmaceutical equipment including SIP systems autoclaves clean utilities and temperature-controlled rooms.
- Develop and execute validation protocols based on engineering documentation and project plans.
- Support the review and approval of SOPs protocols change controls deviations and CAPAs.
- Perform quality system tasks using Document Management Systems (DMS) LIMS and Track Wise
- Collaborate with Operations and Quality teams to ensure compliance and audit readiness.
- Complete other duties as assigned.
Requirements:
- Bachelors degree (strongly preferred).
- Minimum of 4 years of experience in a manufacturing or GMP-regulated environment.
- Working knowledge of equipment validation principles and regulatory standards.