Equipment Validation Engineer II

Job Description

Job Description

Technical Source is looking for an Equipment Validation Engineer II who will be responsible for the development and execution of validation and commissioning protocols for general equipment in Biopharma facility. The position requires knowledge of Biopharmaceutical equipment, cGMP, and CIP protocols. This position is 100% onsite with no remote work.

Job Responsibilities:

• Perform and support execution of validation protocols/projects
• Develop, review, and redline URS/FRS/DDS
• Support change management processes, project level customer communications and coordination efforts
• Prepare and execute commissioning documents
• Prepare and execute IOQ documents and summary reports
• Maintain project lifecycle documentation in accordance with internal and client procedures

Qualifications:

• Bachelor's degree in engineering, science, or related field with at least (3) years of experience or Master's degree in engineering, science, or related field with one year of experience in equipment qualification in Biotechnology or Pharmaceutical cGMP environment
• Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards daily
• Experience with parts washers and cleaning validation is highly desired
• Familiar with various equipment used in pharmaceutical/biotech manufacturing areas
• Experience with change control process in pharmaceutical industry