Commissioning, Qualification and Validation Professional
2 weeks ago
This is a highly challenging and rewarding role for an experienced Commissioning, Qualification and Validation (CQV) professional to join our dynamic team in the life sciences industry.
As a CQV Engineer, you will be responsible for ensuring that facilities, equipment, and utilities are commissioned, qualified, and validated in accordance with industry standards and regulatory requirements.
You will work closely with cross-functional teams to develop and execute validation plans, draft and review validation documentation, and conduct risk analyses.
Key responsibilities include:
- Developing and executing validation plans for facilities, equipment, and utilities
- Drafting and reviewing validation documentation, including protocols, reports, and records
- Conducting risk assessments and design reviews
- Executing FAT/SAT, IQ, OQ, and PQ activities
- Maintaining preventative maintenance schedules and performing risk assessments
- Developing and implementing process improvements to ensure compliance with industry standards
To be successful in this role, you will need:
- A 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' experience performing CQV activities within a GMP environment
- Sound industry knowledge, project proficiency, and autonomy expected
- Experience in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment
- Understanding of current risk-based validation approaches
- Experience in authoring, revising, reviewing, and completing controlled documents for validation projects
- Good knowledge of the code of GMP and PIC/S code
- Previous experience in the Life Sciences Industry and GxP Industries required
We offer a comprehensive benefits package, including:
- Competitive salary and bonus structure
- Opportunities for career growth and development
- Flexible working arrangements
- Recognition and reward for outstanding performance
We are committed to providing a positive and inclusive work environment where all employees feel valued and empowered to succeed.
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