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CQV Expert
2 weeks ago
The Commissioning Qualification Validation Engineer will work alongside a talented team in an exciting, developing, and diverse biotechnology landscape. This role is responsible for commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
Key Responsibilities- 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
- 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
We offer a competitive benefits package, including equal opportunity employment, to attract and retain top talent.
Maintain a workplace culture that values diversity, equity, and inclusion, promoting a collaborative and innovative environment.
What We Offer- A dynamic and supportive team environment
- Opportunities for growth and development
- A comprehensive benefits package
