CQV ENGINEER

The Company
A well established organization operating in regulated manufacturing and engineering environments. The company focuses on quality, compliance, and reliable system performance aligned with global regulatory standards.

Role Description
The CQV Engineer is responsible for providing quality oversight for commissioning, qualification, and validation activities. This role supports new system introductions, change management, and ongoing compliance initiatives. The position works closely with engineering and operations teams to ensure validated and compliant systems.

Responsibilities
- Provide quality oversight for commissioning, qualification, and validation related engineering projects
- Support new system introductions by acting as a technical quality resource
- Apply risk based validation strategies in line with the Site Validation Master Plan
- Review and approve initial validation, change based validation, and periodic revalidation documentation
- Develop and implement strategies for process and system changes
- Collaborate across functions to support organizational quality objectives
- Prioritize work to ensure alignment with departmental goals
- Ensure compliance with applicable regulatory requirements, GMPs, and GLPs
- Identify deviations, perform impact assessments, and support corrective actions
- Support inspections, audits, and statistical process control activities
- Assist with internal and external compliance audits when required

Requirements
- Experience in commissioning, qualification, and validation within regulated environments
- Strong knowledge of GMP and GLP requirements
- Experience with risk based validation approaches
- Ability to review and approve validation documentation
- Experience with deviation and impact assessments
- Strong problem solving and analytical skills
- Ability to work independently with minimal supervision
- Effective communication and cross functional collaboration skills

Other Information
Audit support may be required
On site role

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