Commissioning Qualification Validation Engineer

Requirements

• Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience.
• 3+ years’ experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
• Sound industry knowledge, project proficiency, and autonomy expected.
• Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, etc.
• Understands current risk-based validation approaches.
• Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
• Experience with system impact assessment and risk assessment.
• Good knowledge of the code of GMP and PIC/S code.
• Previous experience in the Life Sciences Industry is required.
• Previous experience in GxP Industries are required.
• Must be adaptable, customer service oriented, have a positive attitude.
• Excellent organizational skills.
• High attention to detail.
• Must have strong written and verbal communication skills.