jobs in Hyde Engineering + Consulting

Kerja Sepenuh Masa, CQV Engineers di Hyde Engineering + Consulting - Maukerja

CQV Engineers

Hyde Engineering + Consulting

Undisclosed

Sepenuh Masa

Singapore

Kongsi
Simpan

Lokasi Kerja

  • Singapore

Penerangan Kerja

Tanggungjawab

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.


Peringatan Penting

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