Validation Specialist

Job Description

This position is responsible for preparing and executing validation protocols for cGMP processes, production/laboratory equipment, cleaning procedures, and software in compliance with Q7. The Validation Specialist will assist with and write final reports for executed validation protocols.

Responsibilities:

• Provide technical assistance to other Validation staff and all other departments regarding validation issues.
• Write and/or revise department and company SOPs.
• Write and/or review validation and qualification protocols (including specification documents, impact assessments, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Process Validations, and Cleaning Validations).
• Serve as Validation representative for cross functional projects.
• Complete qualification/validation protocols (including final reports).
• Participate in external audits (customer, FDA, etc.).

Education and Requirements:

• Bachelor's Degree or above in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline
• 2+ years of related pharmaceutical experience