Biopharma CQV Engineer: Commissioning & Validation

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

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.