CQV Engineer

CQV Engineer

Location : IN

Duration : 6 months

Key Responsibilities :

Develop and execute CQV protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Participate in commissioning activities such as FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and system walkdowns.

Review and approve design documents, specifications, and vendor documentation to ensure compliance with GxP requirements.

Prepare validation plans, risk assessments, summary reports, and other lifecycle documentation.

Support change control, deviation management, and corrective / preventive actions (CAPA) related to validated systems.

Collaborate with engineering, QA, manufacturing, and maintenance teams to ensure successful system implementation and qualification.

Maintain validation traceability and ensure alignment with project schedules.

Ensure all activities comply with company policies, SOPs, and current Good Manufacturing Practices (cGMP).

Qualifications :

Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field) or Life Sciences.

6 7 years of experience in CQV or validation within the pharmaceutical, biotech, or medical device industry.

Strong knowledge of FDA, EMA, GAMP 5, ISPE Baseline Guides, and other applicable regulatory guidelines.

Experience with utilities (e.g., purified water, WFI, HVAC, compressed air), process equipment, and cleanroom environments.

Familiarity with computerized system validation (CSV) is a plus.