Validation Specialist

2 days ago


Oro Valley, Arizona, United States Solü Technology Partners Full time

{"Responsibilities": "
\t• Develop and execute validation protocols to ensure compliance with regulatory requirements.
\t• Collaborate with cross-functional teams to plan and execute validation activities.
\t• Conduct process validation, cleaning validation, CSV, commissioning, IQ, OQ, and PQ studies.
\t• Resolve technical issues and track and expedite the review and sign-off of qualification documentation.
\t• Support the execution of validation activities and interact with individuals from different departments.
\t• Drive the completion of validation efforts according to deadlines.
\t• Develop and maintain departmental procedures required for validation.
\t• Assist during internal and 3rd party audits related to validation requirements.
\t• Initiate CAPAs, NCRs, and Change Requests where required and assist with investigations.
\t• Assist with identifying maintenance and calibration requirements.
\t• Coordinate suppliers related to validation activities.
\t• Perform validation administration tasks such as updating the validation plan and maintaining databases.
\t• Review validation plans, protocols, and SOPs written by other validation team members.
\t• Manage workload arising from unscheduled events.
\t• Perform other duties as assigned by management.
\t•", "Requirements": "
\t• 1-2 years of experience in process validation and testing.
\t• Working knowledge of ISO Quality Management systems.
\t• Scientific or Engineering Degree required.
\t•", "Additional Information": "
\t• Local candidates only.
\t• 100% onsite.
\t• Out of state candidates may apply but must relocate themselves to the Tucson, AZ area.
\t• Solü Technology Partners provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, or genetics.
\t•"}


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