Commissioning & Qualification (CQV) Engineer

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 facilitiesDevelop 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 matricesEnsure compliance with cGMP, FDA regulations, and 21 CFR Part 11 for computerized systemsSupport and/or lead change control processes, deviation investigations, and CAPA implementationEnsure data integrity and proper documentation practices throughout lifecycle activitiesRequired Skills & Competencies:Strong knowledge of CQV lifecycle (Commissioning through Performance Qualification)Experience with pharmaceuticals manufacturing and packaging systemsSolid understanding of GMP, regulatory expectations, and validation principlesFamiliarity with risk management tools (e.g., FMEA)Knowledge of computerized system validation (CSV) and data integrity principlesExcellent documentation, technical writing, and analytical skillsStrong problem-solving and root cause analysis capabilitiesEffective communication and stakeholder management skillsQualifications:Master’s or PhD in Engineering (Chemical, Mechanical, Electrical, Industrial, Automation, or related field)Minimum 3 years of experience in pharmaceutical or GMP-regulated environmentsHands-on experience supporting manufacturing and/or packaging operationsPreferred 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