Are you a Validation Specialist with experience in the pharmaceutical industry? Looking for a new contract role?
My client, a leading pharmaceutical organization in NJ, is seeking talented Validation Engineers with good CSV experience to join on a contractual basis.
As a Validation Engineer, you will be responsible for ensuring all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Area of Responsibility:
• Prepare and execute URS, IQ, OQ, and PQ protocols, along with summary reports, for production and packaging equipment, utilities such as HVAC, air compressors, boilers, purified water systems, area qualification, and temperature mapping studies of warehouses and storage areas.
• Ensure timely and compliant execution of assigned validation activities in accordance with current cGMP requirements.
• Coordinate commissioning activities for engineering projects involving new areas and equipment.
• Review and execute PPV (Periodical Performance Verification) of equipment.
• Develop calibration plans for new equipment.
• Prepare and conduct training on the setup, operation, cleaning, and maintenance SOPs.
• Identify, investigate, and troubleshoot deviations for multiple concurrent projects.
• Prepare documentation for personnel flow, incoming and finished material flow, and waste flow within the facility.
• Assist in the preparation of responses for internal audits, FDA, DEA, and other agency audits.
• Prepare, review, approve, and maintain Validation Project Plans, Summary Reports, and other validation lifecycle documents.
• Write and complete investigations in a timely manner.
• Create and close all change controls, CAPAs, and investigations promptly.
• Develop SOPs for facilities and utilities.
• Monitor work order status, ensuring they are completed correctly and filed appropriately, and follow up with maintenance mechanics to close open work orders promptly.
Some of the skills that Validation Engineers are required to possess include:
• A minimum of 4+ years of experience in a cGMP-regulated environment
• Background in pharmaceuticals or biotechnology
• Strong understanding of regulatory requirements
• Proven experience in qualifying computerized systems in compliance with Data Integrity policies and regulatory standards
This is a fantastic opportunity to join a large pharmaceutical organisation in New Jersey.