Data Analysis-Jobs in Malaysia

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Assistant Staff Engineer- Validation

Company: B. BRAUN MEDICAL IND. S/B

Functional Area: Quality

Working Model: Hybrid

Requisition ID: 3626

Are you passionate to be in the role asAssistant Staff Engineer- Validation ? Do you have experience in computerized system/ software (CSV/CSA) validation? If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!

As aAssistant Staff Engineer- Validation at B. Braun you will play a vital role in…

Your key responsibilities:

• To plan, conduct, and follow-up on validation exercises in accordance with BMI Validation SOPs, such as Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification, and releasing the Final Validation Report for all medical devices production equipment and products.
• This includes assisting and reviewing inspection procedures for In-line Test Stations, following up on corrective actions requested by the Validation Team, ensuring documentation availability at production in accordance with ISO 9001, ISO 13485, cGMP, and USFDA-21 CFR Parts 820 QSR, performing visual and functional tests for products during Operational Qualification, and documenting all findings, actions, and results in checklists during each qualification.
• Train production personnel on the usage of documents such as Process Cards and Machine Adjustment Cards, assist the QM department in performing process audits and follow up on corrective actions implementation, prepare and execute department Standard Operating Procedures, ensure that the established validation exercises consistently produce results or products that meet predetermined specifications, and ensure that the validated process demonstrates that controlling, monitoring, and equipment are capable of operating within prescribed parameters.
• Plan and execute qualifications for products, processes, equipment, and other requests, ensuring their effectiveness.
• Provide training to relevant personnel on process controls documentation (Process Cards, Machine Adjustment Cards, In-line Test Stations, etc.).
• Assist Quality Management in the audit process whenever necessary, and support superior in CAPA management, risk management, complaint handling, change control processes, and other quality issues as required.

What you will bring to the team:

• At least 2 years of Medical device/ pharmaceutical and IT manufacturing and experience in product/ process validation activities (eg. DQ, IQ, OQ, PQ) and computerized system/ software (CSV/CSA) validation, challenge test and ITS for medical device. (eg. GxP, GAMP category, 21CFR Part 11, Risk Assessment).
• Technical writing of Validation plan/ protocol and report in English. Able to simulate and test the challenges test in actual qualifications.
• Familiar with ISO 13485 and FDA compliance, latest CGMP practise, statistical tools (e.g. Minitab, Q-stat), Process Risk Analysis (FMEA), Equipment Risk Analysis, CSV/CSA risk.

What sets B. Braun apart?

Founded in Germany in 1839, B. Braun is a leading medical technology company with over 66,000 employees in 64 countries. Specializing in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more, B. Braun develops high-quality products and services that improve global health. In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices.

Established in 1972, B. Braun Medical Industries in Penang is the regional headquarters for APAC.With more than 7,000 employees, the plant located in Penang is among the largest manufacturers of medical, surgical and pharmaceutical products not only in Malaysia but also in the APAC region.It also houses the Centre of Excellence for Intravenous Access.

What can we offer you?

• Long service award
• Medical insurance
• Training and development programs
• Education assistance program

What’s next?

Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the interview. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.

To find out more about our commitment to diversity clickhere