Validation Engineer (Medical Device)

SteriPack Asia Sdn Bhd (Trading as Ensera) – Klang, Selangor

We are hiring a highly dedicated Validation Engineer who will manage specification, process validation, test method validation, stability study and transportation study at our Medical Device / Pharmaceutical sector.

Employee Benefits : -

Good Basic Salary based on experience

Working with stable & well-established company

Strategic location – safe environment

Attendance Allowance

Performance Bonus and Annual Increment

Medical Benefits and Group Insurance Coverage

Long Term Service Award

Birthday Gift for employees

Flexi Working Hour

Job Responsibilities : -

Manage the validation procedure (including equipment, process & test method) and validation master list.

Establishing validation documents and carry out validation activities including performance qualification and test method validation.

Conduct periodic validation review (PVR) in timely manner and perform revalidation when required.

Generate stability study documents and execute stability study as requested by customers.

As an admin to manage test equipment (such as tensile tester, smart scope, etc) and ensure the test equipment are operated according to requirement.

Manage customer change requests (including documentation, QAD update, etc)

Revise raw material / product specification when required.

Identify and initiate improvement activities through analysis of data from manufacturing records such as capability study, risk analysis, etc.

Leading / supporting non-conformance investigation activities derived from internal / external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.

Establish stability study and transportation study documents and execute as per customer requirement.

Provide support in internal, supplier and external audit process.

Keep abreast of new technology, have in-depth knowledge of products / raw material in order to provide technical support for new product introduction or improvement projects.

Comply with all approved standard operating procedures, work instruction and guidelines that had been trained on.

Attend to any other job as assigned by superior and complete the assignment given within the agreed time frame.

Job Requirements : -

Candidate must possess at least Degree in Science / Chemistry Engineering or equivalent.

At least 3 years’ working experience , preferably in Medical Device industry .

Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.

Have similar experience working in cleanroom environment.

Able to work in a team and under minimum supervision.

Strong interpersonal, analytical and problem-solving skills.

Initiative, proactive, resourceful, able to multi-tasks and work independently.

Good written and verbal communication skills in English and Bahasa Melayu

Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us. Click that ‘ Quick Apply ’ button and we will talk to you soon.

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