{"id":2900282,"url":"https://alion.io/job/ambu-senior-npi-engineer-process-validation-i","title":"Senior NPI Engineer (Process Validation) I","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["George Town, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":14500,"max_usd":33000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":7932},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-20T06:02:54Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-21T18:37:50Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"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.\nKey responsibilities\nYour main responsibilities will include:\nParticipate in establishing validation strategy and scope for new production line set up and design changes.\nAccountable for process validation activities which includes creating protocols, executing tests and compiling reports.\nSupport activities on defining process requirements for validation, plus the test methods.\nCollaborate with project stakeholders to ensure process validation are carried out effectively and successfully to meet project objectives.\nResolve quality issues related to new and existing products, including handle NCRs and CAPAs.\nExecute / support assigned tasks including provide technical or engineering support plus problem solving.\nSuggested candidate profile\nSkills 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:\nA degree in Engineering Mechanical / Mechatronics / Manufacturing Engineering or equivalent.\nFresh graduates are also welcome to apply. However, working experience in Medical Device or Healthcare Industry will be given priority.\nFor 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.\nKnowledge in manufacturing processes, equipment, tests and process validation are added advantage.\nGood communication skills in English, written and spoken.\nAble to work with minimal supervision, be structured and systematic. Able to work in a cross-cultural team.\nUnderstands urgency and commitment to project schedules.\nAble to work in a dynamic international environment.\nAmbu - a visionary and international workplace where your efforts matter\nAmbu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.\nWe offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.","description_format":"text","description_chars":2620,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Malaysia","iso":"MY","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-20T06:02:54Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":0,"expected_fill_days":8,"reasons":["conf:2","velocity","win:early","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/ambu-senior-npi-engineer-process-validation-i","json_url":"https://alion.io/job/ambu-senior-npi-engineer-process-validation-i.json","meta":{"generated_at":"2026-10-21T19:12:40Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":27163,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-senior-npi-engineer-process-validation-i"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fambu-senior-npi-engineer-process-validation-i"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fambu-senior-npi-engineer-process-validation-i"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/ambu-senior-npi-engineer-process-validation-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-senior-npi-engineer-process-validation-i"}]}