Commissioning & Qualification (CQV) Engineer

Commissioning & Qualification (CQV) Engineer at Infotree Global Solutions Commissioning & Qualification (CQV) Engineer at Infotree Global Solutions in Hollywood, Florida Posted in 1 day ago.

Type:

full-time

Job Description:

Job Summary:

The CQV Engineer is responsible for leading commissioning, qualification, and validation activities for manufacturing and packaging equipment, facilities, utilities, and computerized systems. This role ensures all systems are designed, installed, tested, and operated in compliance with cGMP, regulatory requirements, and industry standards.

Key Responsibilities:

Lead commissioning, qualification, and validation (CQV) activities for manufacturing and packaging equipment, utilities, and facilities Develop and execute risk-based

IQ/OQ/PQ

protocols aligned with Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) Prepare and review qualification documentation, including protocols, reports, and traceability matrices Ensure compliance with c

GMP, FDA

regulations, and 21 CFR Part 11 for computerized systems Support and/or lead change control processes, deviation investigations, and CAPA implementation Ensure data integrity and proper documentation practices throughout lifecycle activities

Required Skills & Competencies:

Strong knowledge of CQV lifecycle (Commissioning through Performance Qualification) Experience with pharmaceuticals manufacturing and packaging systems Solid understanding of GMP, regulatory expectations, and validation principles Familiarity with risk management tools (e.g., FMEA) Knowledge of computerized system validation (CSV) and data integrity principles Excellent documentation, technical writing, and analytical skills Strong problem-solving and root cause analysis capabilities Effective communication and stakeholder management skills

Qualifications:

Master's or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related field) Minimum 3 years of experience in pharmaceutical or GMP-regulated environments Hands-on experience supporting manufacturing and/or packaging operations

Preferred Qualifications:

Experience with automation systems (PLC/SCADA, DCS) Exposure to regulatory audits (FDA, EMA, etc.) Certification or training in validation, quality systems, or project management