CQV Engineer

The CQV Engineer is responsible for executing Commissioning, Qualification, and Validation activities in support of facility, utility, and equipment projects within a GMP-regulated environment. The ideal candidate will have hands-on CQV experience and a strong technical understanding of pharmaceutical/biopharmaceutical processes. Experience with filling lines is considered a strong asset.

Key Responsibilities:

• Prepare and execute CQV documentation, including protocols (DQ, IQ, OQ, PQ) and summary reports for assigned systems and equipment.
• Perform commissioning and qualification activities for process equipment, utilities, and related computer systems.
• Support development of project documentation such as User Requirements Specifications (URS), Functional Specifications, and Traceability Matrices.
• Conduct field inspections, participate in FAT/SAT, and troubleshoot CQV-related issues as they arise.
• Ensure all activities are performed in compliance with internal procedures and external regulatory requirements (FDA, EMA, etc.).
• Contribute to deviation investigations, change controls, and CAPA processes related to CQV activities.
• Collaborate closely with project teams, maintenance, QA, and external vendors.
• Maintain accurate, organized documentation and proactively track progress versus project timelines.
• Support regulatory inspections and internal/external audits with respect to CQV activities.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 5 years of experience in commissioning, qualification, validation, or QA in a GMP-regulated industry (pharmaceutical/biotech preferred).
• Solid knowledge of relevant regulatory standards (cGMP, FDA, EU GMP, ICH Q8/Q9/Q10).
• Experience developing and executing IQ/OQ/PQ protocols.
• Excellent technical, problem-solving, and documentation skills.
• Strong communication and teamwork abilities.

Preferred Qualifications:

• Experience with pharmaceutical or biopharmaceutical filling lines (liquid and/or sterile filling equipment).
• Knowledge of automation and computerized systems validation (SCADA, PLC, DCS, or MES).
• Familiarity with risk-based validation approaches.

Personal Attributes:

• Detail-oriented, well-organized, and able to work independently and in teams.
• Proactive approach and willingness to learn new systems and technologies.
• Strong commitment to quality and compliance.

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