Validation Engineer

Job Responsibilities:

• Responsibilities associated with this position are directly associated with equipment qualifications and process validations in a GMP manufacturing facility
• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation
• Initiate, author, revise, review and complete controlled documents for projects
• Review and qualify equipment for commissioning, qualification, and validation activities
• Write and review FDA and GMP documents and technical specifications
• Support and provide validation oversight for capital expansion projects/build outs
• Assist in authoring validation lifecycle documentation
• Will work in close collaboration with other groups such as Operations, Quality, Product Development, Engineering, and Project Management

Qualifications:

• Bachelor's degree in related discipline
• 2+ years of validation experience required
• 2+ years of GMP (pharmaceutical) experience
• Cleaning validation experience desired
• Must be able to work on site
• Must be able to work well with others