• Commission, qualify, and validate, GxP facilities, equipment, and utilities in assigned projects.
• Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
• Draft and execute validation documentation such as:
• Validation Project & Master Plans
• Requirement Specifications (URS, DS, FS)
• IQ and OQ Test Scripts
• IQ/OQ/PQ Protocols
• Validation Summary Report
• Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
• Conduct preventative maintenance and perform risk assessments.
• Recommended process improvements where needed ensuring compliance with industry standards.
• Establish validation standards and develop performance testing and quality control measures.
• Execute process equipment and clean room validation.
• Clearly communicate all progress, updates, and action steps for assigned projects. Collaborate with multiple departments on assigned project activities and deliverables.
• Additional duties as assigned. 

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.

Benefits