"Alerted.org

Position Summary & Responsibilities:

Develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments. Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies.

+ Write and execute protocols and test cases for validation. Develop and execute equipment, material, cleaning, and process validation protocols including statistical analysis of data generated from validation studies and compiling relevant documentation. Assist on the execution of validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site initiatives.

+ Assure validation documentation is generated, reviewed and approved in accordance to site and global procedures.

+ Review and approve change controls for laboratory and production systems. Support change control processes through assessment of system changes and identifying the extent of qualification or requalification activities as needed. Support Change Requests, CAPA, investigations, Non-Conformances, and Waivers as QA function.

+ Ensure validated state is maintained by performing periodic review of equipment, processes, etc.

+ Revise and update validation SOPs and Site Validation Master Plan as required.

+ Ensure all items on the requalification and periodic review schedule are performed on time.

+ Continuously improve and update the validation program.

+ Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.

+ Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Education, Skills, & Experience:

+ Bachelor’s Degree in Engineering or Life Science and a minimum of four (4) years of Validation experience in a related industry.

+ In lieu of a degree, a High School Diploma/GED with 8 years of Validation experience is also accepted

+ Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Also requires understanding of cGMPs and validation / qualification concepts.

+ Must be able to identify and understand critical functions and features of equipment and systems.

+ Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new validation methodologies.

+ Requires effective technical writing and oral communication skills to interact across all levels of the organization.

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