CQV Engineers - MAL

Hyde Engineering + Consulting; Kuala Lumpur; On-site; MYR 66,960 - 111,600; Full time

Job summary

A leading engineering consultancy in Kuala Lumpur is seeking a Commissioning & Qualification Engineer. The role involves developing and executing protocols for bioprocess equipment, including validation and commissioning of various systems. Candidates should have 5-15 years of relevant experience, strong knowledge of utilities, and a BE/B.Tech/Diploma in relevant fields. Strong communication and organizational skills are essential, alongside experience in GMP environments.

Qualifications

• 5-15 years in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines with advanced technical knowledge.
• Industry experience related to cGMP drug manufacturing, validation, and chemical process design.

Responsibilities

• Develop risk assessment, validation plans, protocols, and reports for qualification and validation.
• Develop and execute Commissioning and validation Protocols for Bioprocess Equipment.
• Review, analyze and interpret system performance data for completed validation and prepare final report packages.

Skills

Validation experience

Technical knowledge on utilities

Strong verbal and written communication skills

Excellent organizational and time utilization skills

Ability to work independently and within project teams

Education

BE/B.Tech/Diploma in Biotechnology, Mechanical Engineering, Chemical Engineering

Tools

Documentum

Maximo

Microsoft Office products

Job description

Overview

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.
• 5-15 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.