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.