Quality Validation Engineer

SteriPack Group; Selangor; On-site; MYR 45,000 - 60,000; Full time

Job summary

A leading company in the Medical Device and Pharmaceutical sector seeks a dedicated Quality Validation Engineer. This role involves managing validation procedures, conducting stability studies, and ensuring compliance with industry standards in a cleanroom environment. Candidates should have a degree in Science or Chemistry Engineering and at least three years of relevant experience. Join us to grow your career and make an impact in the medical field.

Qualifications

• 3 years working experience in the Medical Device industry is preferred.
• Knowledge of ISO 13485, GMP, and FDA 21 CFR Part is beneficial.
• Experience working in a cleanroom environment.

Responsibilities

• Manage validation procedures including equipment and process validation.
• Generate and execute stability and transportation study documents.
• Conduct periodic validation reviews and support audit processes.

Skills

Analytical skills

Problem-solving skills

Interpersonal skills

Communication skills

Education

Degree in Science/Chemistry Engineering

Job description

Position Summary:

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

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
• Computer literate

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 apply button and we will talk to you soon.