Designation: C&Q Engineers
Company Name :Hyde Engineering and Consulting India Pvt Ltd
Company Type: Automotive
Location: Hyderabad and Bengluru
Experience:4 - 9 years
Salary: as per performance
Qualification: B.Tech/B.E. in Mechanical
Job description:
Looking for candidates who can join us immediately or those who have a short notice period
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, Clean Utilities, Black Utilities 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.
- 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
- Should co-ordinate with QA dept. for getting approvals for documents
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