Validation Engineer

TRAQUE PTE. LTD.; Singapore; On-site; SGD 60,000 - 75,000; Full time

Job summary

A leading engineering solutions provider in Singapore is searching for a Validation Engineer to support the validation of biopharmaceutical equipment and systems. Candidates should have at least 3 years of experience in commissioning and validation, preferably in a pharmaceutical setting. Strong interpersonal and communication skills are crucial. Immediate availability is preferred. This role offers an exciting opportunity for growth in a dynamic work environment.

Qualifications

• Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes.
• Experience working in a pharmaceutical or GMP/GLP environment preferred.
• Excellent written and verbal English skills are essential.

Responsibilities

• Validate biopharmaceutical equipment, facilities, and computer systems.
• Coordinate with vendors for equipment installation and commissioning.
• Develop and execute qualification protocols and test plans.

Skills

Interpersonal skills

Communication skills

Customer-oriented work ethic

Flexibility

Problem-solving

Education

University degree in Engineering, Life Sciences or equivalent

Tools

Kneat

Job description

Introduction

We at Traque are on an exciting journey of growth and are looking for a dynamic Validation Engineers to help us achieve our vision to become "your first-choice industrial solution provider".

Traque provides comprehensive consulting and engineering solutions, working with multinational pharmaceutical clients to R&D facilities - across all spectrums of the industry from chemical API, secondary, biopharmaceutical to medical device designers and manufacturers.

Key Duties:

The Validation Engineers are responsible for validation of biopharmaceutical equipment, facilities, utilities, laboratory equipment and computer systems in new and modified pharmaceutical and life science facilities. This includes working or leading a team, supporting the purchase, installation, commissioning and qualification of biopharmaceutical equipment, utilities and processes.

• Sourcing, specification and selection of new equipment based on minimal user input
• Coordinating with vendors and working with the design teams to ensure a fit for purpose system
• Managing installation and commissioning of the equipment (with vendor support)
• Qualification of the equipment, including: - preparation of protocols and test plans, execution of the protocols including sample and reagent preparation, preparation of qualification summary reports, and investigation of deviations
• Supporting process technical transfer: - including feasibility studies, equipment sizing, process design, process validation and process optimisation
• User training in equipment use and operation
• Supporting cleaning and process validation studies, including cleaning strategy development, protocol development, execution assistance

Job Requirements

• University degree in Engineering, Life Sciences or equivalent
• Minimum 3 years' experience in commissioning and/or validation of biopharmaceutical equipment and processes
• Experienced working in a pharmaceutical or GMP/GLP environment is preferred, although cross-industry expertise is welcomed
• Preferably experienced with using Kneat
• Experienced working under Quality Management Systems
• Excellent interpersonal and communication skills
• Goal-oriented, dynamic, and high sense of responsibility
• Able to work flexibly and under pressure
• Able to work self-reliantly
• Possess excellent customer-oriented work-ethic
• Professional appearance and demeanor
• Very good written and verbal English skills
• Immediate availability is preferred