Validation Engineer III

Coordinates testing activities to ensure equipment, machinery and systems are performing as expected. Designs and develops validation studies and test cases. Writes and reviews validation documentation as it relates to mechanics, computers and other equipment. 5-10 Years Experience. See attached Job Description, in addition to what is below for further details.

The Validation Engineer III ensures all GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines.

This position supports the following organizations:Operations, Quality Assurance, customers, and regulatory bodies with scientifically sound, documented evidence that systems and processes perform as required to ensure a robust and compliant manufacturing environment.

This position supports the following areas of Validation, as needed:

Equipment Validation (facilities, utilities, equipment, cleanroom qualification)

Computerized Systems Validation (including automation) understanding of 21CFRPart 11 and Data Integrity preferred.

Planning and completing the work of Validation. Assessing workload and managing resource deployment to achieve validation goals. Responsible for managing and tracking execution of validation activities against project timelines.

This role is within the scope of routine operations and capital project validation activities.

Develop and maintain validation master plans, validation protocols, and project plans. Review and approve completed protocols/reports for completeness, cGxP compliance and acceptability of data.

Provide oversight and technical expertise on change control assessments, review and approval of SOPs, and validation tasks for GxP equipment and systems, associated validation activities to ensure compliance with regulatory requirements

Provide Regulatory Validation guidance to all pharmaceutical/biotech facilities. Interface with customers on topics of validation and project management as required.

Perform other duties as assigned.

*This position has the ability to work remote up to 1-2 days/week