Job Title: Validation Specialist

Work Location: Oklahoma County, Oklahoma

Summary:

This entry to mid-level position focuses on ensuring compliance with current Good Manufacturing Practices (cGMPs) through the design, execution, and closure of validation protocols. The role requires both independent and collaborative work, interfacing with various organizational levels to support validation activities and continuous improvement.

Responsibilities:

• Develop and implement validation policies and procedures to maintain compliance with global regulations and standards.
• Coordinate and execute validation activities in alignment with site management and business objectives.
• Participate in review boards to assess and approve validation processes and outcomes.
• Identify, troubleshoot, and resolve validation-related issues proactively.
• Author, execute, and close documentation for Installation, Operational, and Performance Qualifications (IQ/OQ/PQ).
• Review, author, and revise Standard Operating Procedures and manufacturing process documentation as needed.
• Support documentation and follow-up for Corrective Preventative Action plans and Change Control processes.
• Assist with validation support for new or modified equipment, including data entry into calibration software and preparation of technical reports and risk analyses.

Qualifications:

• Experience in validation within a regulated manufacturing environment.
• Ability to develop, execute, and close validation protocols and related documentation.
• Familiarity with cGMPs and global regulatory standards.
• Strong written and verbal communication skills in English.
• Ability to manage multiple priorities and work both independently and as part of a team.
• Experience with Standard Operating Procedures, Corrective Preventative Action plans, and Change Control processes.
• Proficiency in preparing technical reports, risk analyses, and validation master plans.
• Continuous attention to detail and ability to handle visual and mental tasks related to manufacturing functions.

Published Category: Quality & Validation