Job Description

Job Title: Entry-Level CQV Engineer

Job Description:

As an Entry-Level CQV Engineer, you will support the commissioning, qualification, and validation activities for various systems and equipment to ensure compliance with industry standards, regulations, and internal procedures. This position offers an excellent opportunity to gain hands-on experience in the pharmaceutical and life sciences sectors while contributing to high-quality manufacturing and regulatory compliance efforts.

Qualification Activities:

Support the execution of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
Review and approve documentation related to qualification and testing.
Assist in the assessment of system performance to ensure compliance with regulatory requirements and industry best practices.

Validation Activities:

Help prepare and execute validation protocols for manufacturing processes, equipment, and computerized systems.
Assist in ensuring that processes and systems are validated and maintained in accordance with applicable regulations (e.g., FDA, EMA, ISO).
Review validation documentation for completeness and compliance.

Documentation and Reporting:

Maintain accurate and complete documentation for all CQV activities.
Support the preparation of final reports and deliverables that detail commissioning, qualification, and validation results.
Ensure that all documentation is compliant with regulatory standards and industry guidelines.

Collaboration and Communication:

Skills:

Basic understanding of engineering principles and scientific processes.
Familiarity with industry standards such as GxP, FDA, and ISO regulations.
Strong attention to detail and documentation skills.
Good problem-solving abilities and a proactive attitude.
Effective communication and teamwork skills.
Ability to work in a fast-paced, regulated environment.

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