Last Updated: 2017-07-24
Job Ref #: 5668
Location: Sandpoint, ID
Status: Position Available
Our client has an immediate need for a Validation Specialist. If you are looking for your next career move, not just a job, we have an exciting opportunity to join a growing and innovative manufacturing company where you will be valued for your contribution. The company offers a competitive base and incentive salary program, as well as a comprehensive benefits package.
You will spend your time between the Sandpoint ID and the Spokane facility.
As the Validation Specialist you will develop and implement protocols to validate, calibrate, and qualify equipment and processes for the company, ensuring compliance with all applicable regulations.
•Design and draft validation protocols for processes and equipment.
•Design and draft calibration protocols for equipment.
•Create draft validation protocols.
•Execute validation and calibration documents.
•Implement FDA/ISO documentation for equipment and/or processes including SOPs and preventive maintenance documents and forms.
•Work to ensure that calibrations are fully integrated to demonstrate that equipment consistently functions as intended to maintain regulatory compliance for the facility.
•Perform and document experiments to demonstrate that equipment and processes consistently function as intended to maintain regulatory compliance of the facility.
•Write draft reports based on data gathered during execution of validation documents.
•Support Engineering in compliance with FDA/ISO regulations.
•Assist with writing Standard Operating Procedures (SOPs), Preventive Maintenance procedures, and other documents for equipment and processes as needed.
•Consult with other departments on FDA/ISO regulatory compliance as requested.
•Perform initial reviews of equipment usage to determine if systems need to be re-validated or calibrated.
•Evaluate external calibration protocols and schedule external vendors for maintaining calibration needs of the organization.
•Evaluate external validation protocols.
•Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
Bachelor’s degree in Science, Engineering, or a related field, or an equivalent combination of education and experience.
Three years’ experience in Validation.
One year’s experience in calibration.
Knowledge of the Scientific Method.
Knowledge of ISO and FDA requirements for GMP/GLP practices.
Experience working in a FDA regulated manufacturing facility.
Ability to work independently with minimal direction.
Ability to prioritize workload to meet established deadlines.
Familiar with Chemistry, Microbiology, and Engineering terminology.
Ability to perform basic statistical calculations and analysis.
Experience creating and maintaining documentation and reporting.
Proficient in Microsoft Office.
External qualification to a recognized certifying organization for calibrations is a plus, but is not required.