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Process Validation Expert

2 months ago

Tucson, Arizona, United States Apollo Professional Solutions Full time
Job Description

Overview

The Validation Engineer will play a crucial role in ensuring that validation requirements are met for all existing and new equipment, facilities, utilities, and processes at Apollo Professional Solutions. This involves preparing and executing detailed validation protocols that meet relevant testing standards and regulatory requirements.

Key Responsibilities

  • Protocol Development: Design and draft validation sampling and testing plans/protocols to ensure compliance with regulatory standards.
  • Study Execution: Execute and report on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ, and PQ studies.
  • Troubleshooting: Resolve technical issues encountered during study execution.
  • Documentation Management: Track and expedite the review and sign-off of qualification documentation.
  • Collaboration: Interact with individuals from different departments to plan, execute, and complete qualification activities.
  • Project Management: Drive the completion of validation efforts according to deadlines.
  • Procedure Development: Write or guide the writing of departmental procedures required for validation.
  • Audit Support: Assist during internal and third-party audits related to validation requirements.
  • Quality Assurance: Initiate CAPAs, NCRs, and Change Requests where required and assist with investigations.
  • Maintenance and Calibration: Assist with identifying maintenance and calibration requirements.
  • Supplier Coordination: Coordinate suppliers regarding validation activities, including obtaining quotes from suppliers.
  • Administrative Tasks: Perform validation administration tasks such as updating the validation plan, maintaining databases, and standard referencing of documentation.
  • Review and Approval: Review validation plans, protocols, and SOPs written by other validation team members.
  • Adaptability: Manage workload arising from unscheduled events.

Requirements

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

Qualifications

Apollo Professional Solutions is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.