{"id":3990306,"url":"https://alion.io/job/coloplast-validation-engineer-mfx","title":"Validation Engineer (m/f/x)","company":{"id":13696,"name":"Coloplast","domain":"coloplast.com","url":"https://alion.io/company/coloplast","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":100,"open_postings":6,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Felgueiras, Portugal"],"countries":["PT"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-09T23:12:08Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-10T05:24:43Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"The Validation Engineer will be responsible for the execution of process and software validation activities under the\norganizations as well as maintaining the validation life cycle of the machines, process, and test method, ensure\ncompliance within external and internal requirements and ensure compliance with the quality management system.\nMajor areas of accountability\nPerforming their job in compliance with the guidelines given;\nDrawing attention to the manager to any difficulties in understanding or following the guidelines;\nDrawing attention to inefficiency of the system;\nEnsure continuous improvement of processes & specifications;\nProvide sparring and support for Operations in CMPT regarding quality issues and help improve overall quality understanding during validations;\nExternal / internal Audit support;\nMaintain high quality understanding in operations through support and guidance of operators daily;\nEssential Duties / Responsibilities\nBelow duties & responsibilities apply when the site opens for production or when applicable training is performed for each of the topics where such training is required.\nGeneral:\nIssuing, completing, or approving validation documentation (protocols, deviations, reports, etc.);\nPerforming Installation, Operational, and Performance Qualification of equipment, instruments, and machines;\nPerforming validation of test methods for continues data and attributes;\nPerforming assessment about software changes and perform validation of software as appropriate;\nCreation of software validation plans and validation strategic plans as required;\nIssuing, updating, and approving Process Risk assessments;\nInvestigating abnormal test results (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);\nTroubleshooting validation issues (close collaboration with Quality Engineer and Production Support Engineers and stakeholders);\nHandling of Process validation, Software validation and Risk assessments related Change Request tasks;\nCollecting, organizing, and documenting test data;\nStatistical analysis of data for process and test methods validation;\nEnsuring accurate records of all validation activities.\nMaintaining validation documentation throughout the validation life cycle.\nParticipation on cross-functional teams related to projects for new machines, transfer machines, item extensions or any other project where validation assessment or validation activity is needed;\nDrawing attention to the manager to any difficulties in understanding or following the guidelines;\nDrawing attention to inefficiency of the system;\nTake responsibility for those safety aspects identified for the given position.\nDepartment:\nSupport Validation Training in FEL Quality\nRequired knowledge, skills & abilities\nCross-functional: Self-management, decision making and critical thinking, collaboration & communication.\nFunctional competencies: Coloplast specific knowledge of quality management system and processes.\nFluent in both spoken and written English \nPreferred qualification\nNewly graduated with a B.Sc., or a M.Sc., or experience in production with quality focus or quality roles combined with relevant courses\nGood English skills in verbal and written form\nStructured and systematic\nConducting own work independently\n\nPursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. \nColoplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability. \nVisit us on Coloplast.com. \nWatch the film. Follow us on LinkedIn.\n62471","description_format":"text","description_chars":4219,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Supplies & Consumables","Wound Care"],"lifecycle":[{"event":"open","at":"2026-11-09T23:12:08Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":28,"reasons":["conf:0","win:early","comp:brand"],"computed_at":"2026-11-10T05:40:43Z"},"pay":null,"html_url":"https://alion.io/job/coloplast-validation-engineer-mfx","json_url":"https://alion.io/job/coloplast-validation-engineer-mfx.json","meta":{"generated_at":"2026-11-10T05:40:43Z","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":13183,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":13696},"rest":"https://alion.io/mcp/rest/get_company?id=13696"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcoloplast-validation-engineer-mfx"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fcoloplast-validation-engineer-mfx"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fcoloplast-validation-engineer-mfx"},{"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/coloplast-validation-engineer-mfx\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcoloplast-validation-engineer-mfx"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3990306}},{"tool":"search_jobs","arguments":{"company":"coloplast.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3990306},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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