Equipment Validation Specialist

3 weeks ago


Madison, Wisconsin, United States Germer International Full time

This is a full-time position at Germer International. Are you detail-oriented with a passion for ensuring high quality standards in a pharmaceutical manufacturing environment? Then this role is for you.

The Validation Specialist 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.).

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