CQV Engineers

Position: Commissioning & Qualification Engineer Responsibilities - Develop risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems. - Develop and execute Commissioning and validation Protocols for Bioprocess Equipment’s. - Develop and execute Commissioning and validation of Clean Rooms, HVAC systems, EMS and BMS Systems, Clean utilities and black utilities system. - Develop Protocols and Conduct Tests like HEPA Filter Integrity Testing, Air velocity, Recovery Testing, ACPH, Airflow pattern study, DP monitoring, non-viable particle counting, Viable Particle Counting, etc. - Develop and execute Commissioning and validation of Pharma Process Equipment’s for API, Fill/Finish and OSD. - Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessments. - Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. - Investigate deviations, write investigation reports and create summary reports. - Promote cGMP and regulatory compliance into assigned projects. - Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. - Should have technical knowledge on utilities. - Should have experience in Erection, Commissioning and Qualification of Utilities. - Should have experience and understanding on Pretreatment plant, PW, WFI & Pure Steam. - Hands on Experience with Biopharma Process Equipments. Qualifications & Other Requirements - BE/B.Tech/Diploma in Biotechnology, Mechanical Engineering, Chemical Engineering. - 4-10 years in validation, quality systems, operations, engineering or any combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Validation experience using, traditional, risk based, Hybrid approach. - Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in. - Experience working with Documentum or Maximo a plus. - Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. - Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions. - Strong verbal and written communication skills; excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.