Job Summary:
We are seeking an experienced Sr. Engineer C&Q to lead and execute Commissioning & Qualification (C&Q) and validation activities at a manufacturing site. The role involves ensuring GMP compliance, developing validation strategies, managing engineering projects, supporting audits, and driving standardized validation practices across manufacturing operations.
Key Roles & Responsibilities
Lead and execute Commissioning & Qualification (C&Q), equipment qualification, and validation activities.
Develop, review, and approve validation protocols, reports, SOPs, and technical documentation.
Maintain the Validation Master Plan (VMP), track project progress, and report validation metrics.
Ensure compliance with GMP, FDA regulations, ISO 14001, EHS, and site quality standards.
Lead cross-functional engineering, manufacturing, automation, and validation teams.
Support deviation investigations, CAPA, risk assessments, and resolution of complex technical issues.
Coordinate regulatory audits, inspections, and compliance activities.
Manage project timelines, resources, budgets, risks, and contractor activities.
Drive continuous improvement, validation standardization, and global C&Q initiatives.
Provide technical guidance and mentorship to junior engineers.
Required Skills & Keywords
Commissioning & Qualification (C&Q), GMP, FDA Compliance, Equipment Qualification, Process Validation, Validation Master Plan (VMP), IQ/OQ/PQ, Validation Protocols, Validation Reports, SOP Development, Quality Assurance, CAPA, Deviation Management, Root Cause Analysis (RCA), Risk Assessment, Change Control, Regulatory Audits, Manufacturing Engineering, Automation, Project Management, EHS, ISO 14001, Process Safety Management, Contractor Management, Continuous Improvement.
Interested candidates: Please share your updated CV at:
Key Skills - Senior C&Q Engineer, Commissioning Engineer, Qualification Engineer, Validation Engineer, CQV Engineer, CQV Lead, GMP Validation Engineer, Pharmaceutical Validation Engineer, Biopharma Engineering.
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