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Commissioning, Qualification and Validation Engineer
3 weeks ago
We are seeking a highly skilled and experienced professional to join our team as a Commissioning, Qualification, and Validation (CQV) specialist. This is an exciting opportunity for a talented individual to work in the biotechnology landscape.
The successful candidate will be responsible for:
- Commissioning, qualifying, and validating GxP facilities, equipment, and utilities in assigned projects.
- Drafting and executing validation documentation, including protocols, test scripts, and reports, ensuring compliance with cGMP requirements, regulatory requirements, and quality standards.
- Initiating and coordinating risk analyses, design reviews, and executing FAT/SAT, IQ, OQ, and PQ.
- Conducting preventative maintenance and performing risk assessments.
- Recommending process improvements where needed, ensuring compliance with industry standards.
- Establishing validation standards and developing performance testing and quality control measures.
This role requires a strong understanding of the biotechnology and pharmaceutical industries, with a minimum of 3 years' experience in CQV activities within a GMP environment.
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 a GMP environment.
- Solid industry knowledge, project proficiency, and autonomy expected.
- Experience in CQV of facility/utility/equipment, including PW, HVAC, and process or laboratory equipment, etc.
- Understanding of 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.
This is an excellent opportunity for a motivated individual to take their career to the next level. If you possess the necessary skills and qualifications, please submit your application.
