Department: NPI Process Development & Validation
Employment Type: Full-time
Ambu A/S is currently looking for an NPI Engineer for our Process Validation team to be based in Ambu Global Hub, in Penang, Malaysia.
Key ResponsibilitiesYour main responsibilities will include:
Participate in establishing validation strategy and scope for new production line set up and design changes.
Accountable for process validation activities which includes creating protocols, executing tests and compiling reports.
Support activities on defining process requirements for validation, plus the test methods.
Collaborate with project stakeholders to ensure process validation are carried out effectively and successfully to meet project objectives.
Resolve quality issues related to new and existing products, including handling NCRs and CAPAs.
Execute/support assigned tasks including providing technical or engineering support plus problem solving.
Suggested Candidate ProfileSkills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:
A degree in Engineering Mechanical / Mechatronics / Manufacturing Engineering or equivalent.
Fresh graduates are also welcome to apply. However, working experience in Medical Device or Healthcare Industry will be given priority.
For experienced candidates, technical and documentation skills are good to have to ensure optimal project execution and implementation. It will be an advantage to have relevant experience in FDA requirements, Design Control, Process Validation and ISO 13485.
Knowledge in manufacturing processes, equipment, tests and process validation are added advantages.
Good communication skills in English, written and spoken.
Able to work with minimal supervision, be structured and systematic. Able to work in a cross-cultural team.
Understands urgency and commitment to project schedules.
Able to work in a dynamic international environment.
About AmbuAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.#J-18808-Ljbffr