Hyde Engineering + Consulting
Website:
hyde-ec.com
Job details:
Immediate Joiners Preferred!!!!!
This position shall perform commissioning and qualification of HVAC, Clean Rooms, EMS and BMS Systems in Pharma/Biopharma Facilities.
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 of Clean Rooms, HVAC systems, EMS and BMS Systems
- Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessments
- 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 Protocols and Execute the same for BMS and EMS Systems.
- 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.
Qualifications & Other Requirements
- BS/MS in Mechanical 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
- Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel
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