- 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 Equipment.
Role Requirements:
- BE/B.Tech/Diploma in Biotechnology, Mechanical Engineering, Chemical Engineering
- Minimum 2 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 skill
- 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