Validation Engineer (Medical Background)

Greatech; Bayan Lepas; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading company in factory automation solutions is seeking a Validation Engineer to oversee the creation and execution of validation documentation for various projects. The ideal candidate will have a Bachelor's degree in Engineering and a minimum of 2 years of experience in the medical field, with strong technical writing skills and a good understanding of relevant regulations. You will be responsible for ensuring all validation activities meet quality standards and regulatory compliance while managing multiple projects independently.

Benefits

Medical

Miscellaneous allowance

Education support

Dental

Sports (e.g. Gym)

Parking

Pantry with free flow of beverages and snacks

Qualifications

• At least 2 years of experience in medical-related fields.
• Good knowledge of ISO 13845, ISO 9001, FDA regulations.
• Experience in medical device validation preferred.

Responsibilities

• Create and manage validation exercise documentation.
• Coordinate and lead validation activities.
• Ensure compliance with regulatory requirements.

Skills

Technical Writing

Knowledge of ISO 13845

Knowledge of FDA regulations

Education

Bachelor's Degree in Engineering

Job description

Validation Engineer (Medical Background)

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Responsible for the creation of validation exercise documentation including validation protocol (DQ,IQ,OQ,PQ) and master validation plan.

Coordinate execution of validation activities, work closely with Operations team and related parties to meet validation timeline.

Lead validation execution at customer site by using validation document from customer depending on the requirement for each project.

Review validation protocols and test report to ensure that they are technically correct.

Ensure validation plan and reports are meeting regulatory requirements.

Anticipate problems actively and take appropriate action to mitigate impact.

Responsible for the tracking and managing the resolution of issues generated during validation.

Providing timely status and updates to management as required.

Take responsibility for being quality gateway for your own deliverables.

Manage approval of validation documentation by internal approvers and customers in a timely manner.

Ensure validation protocols and test reports are properly documented.

Line review and verification against the Master Validation Plan(MVP) to ensure all validation activities are properly and completely documented and updating of the MVP in a timely manner such as when there are new validation activities and changes to existing validation.

Work closely with the rest of the validation team members and provide an emphasis on quality and validation best practices.

Follow and submit to best practice in relation to a clearly documents and audit friendly validation process.

Ensure validation documentation is always audit ready.

Job Requirements:

A Bachelor's Degree in Engineering of Mechanical, Mechatronic/Electromechanical or equivalent field.

At least 2 years and above of working experience in medical related field.

Preferably candidate with good knowledge in ISO 13845, ISO9001,FDA 21CFR Part and GAMP5.

Good experience in medical device technical writing and validation/qualification for the processes, systems and equipment.

Good experience in Computerized System Validation will be an added advantage.

Ability to work independently and be self-sufficient while managing multiple projects.

Initiative, proactive, able to work in a team and under minimum supervision.

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Your application will include the following questions:

Which of the following types of qualifications do you have? How many years' experience do you have as a Validation Engineer? What's your expected monthly basic salary? Have you worked in a role where you were responsible for authoring and reviewing technical documentation? Do you have technical writing experience? How much notice are you required to give your current employer? Which of the following languages are you fluent in? How many years' experience do you have as a Validation Officer?

Manufacturing, Transport & Logistics 1,001-5,000 employees

Greatech is designer, manufacturer and integrator of factory automation solutions for solar PV, consumer electronics, automotive & battery industries.

In response to growing markets and increasing competition, we offer automation solutions in various industries in order to meet customer productivity challenges, improve on return on investment and cost effectiveness.

Our design & engineering specialists are committed to develop the best possible automation solutions and use its competent capabilites to serve the sophisticated automation systems needs of multinational customers in this industry.

Besides that, we have in-house manufacturing facility complete with precision machine shop, sheet metal fabrication shop, engineering facility and system aseembly space. We are positioned and comitted to serve the global customers with innovative, cost effective solutions and support.

Greatech is designer, manufacturer and integrator of factory automation solutions for solar PV, consumer electronics, automotive & battery industries.

In response to growing markets and increasing competition, we offer automation solutions in various industries in order to meet customer productivity challenges, improve on return on investment and cost effectiveness.

Our design & engineering specialists are committed to develop the best possible automation solutions and use its competent capabilites to serve the sophisticated automation systems needs of multinational customers in this industry.

Besides that, we have in-house manufacturing facility complete with precision machine shop, sheet metal fabrication shop, engineering facility and system aseembly space. We are positioned and comitted to serve the global customers with innovative, cost effective solutions and support.

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Perks and benefits Medical Miscellaneous allowance Education support Dental Sports (e.g. Gym) Parking Vision Pantry with free flow of beverages and snacks

What can I earn as a Validation Engineer