Equipment Validation Specialist
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
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:
- Bachelor's 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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Average salary estimate
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