{"id":2452002,"url":"https://alion.io/job/nemera-quality-validation-engineer-equipment-validation","title":"Quality Validation Engineer - Equipment Validation","company":{"id":690405,"name":"Nemera","domain":"nemera.net","url":"https://alion.io/company/nemera","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":44,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Buffalo Grove, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":59000,"max_usd":110000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3384},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":".NET","optional":false},{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"C#","optional":true}],"status":"live","first_seen_at":"2026-10-13T13:49:47Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-14T08:12:42Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.\nNemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).\nWe have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.\n The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.\nResponsibilities:\nAssists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost\nIdentify and coordinate resolution of system inefficiencies that contribute to increased quality costs.\nCoordinate and manage the execution of validations and creation of written protocols.\nCoordinate and manage the execution of change control activities.\nAssess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.\nUtilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.\nDevelop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.\nEvaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.\nDevelop product specifications for existing products and assess existing specifications for accuracy and compliance.\nPlan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.\nInteract with suppliers and ensures mutual interpretation of specified requirements to make certain customer requirements and objectives are met.\nSupport implementation and management of quality agreements with assigned suppliers.\nPlan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.\nInteract with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.\nAssist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the audits.\nAssist in maintaining ISO and FDA QSR quality systems compliance.\nExecute specific responsibilities as defined within the company quality operating system.\nSupport and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.\nIdentify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.\nOther duties as assigned.\n Preferred/Required Education/Skills:\nBachelor’s degree in Engineering, Science or related field.\n3+ years' of experience in a Quality position strongly preferred.\nExperience in the Medical Device industry strongly preferred (ISO13485)\nExperience with technical writing, IQ/OQ/PQ is preferred\nExperience with equipment validation is preferred\nExperience working onsite in Manufacturing is strongly preferred\nExcellent communication skills with the ability to understand, read, write and speak English required.\nMust have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.\nSix-sigma experience, training or certification preferred.\nIntermediate level computer skills, including Microsoft Office applications required.\n SAP experience preferred.\nAbility to work independently from verbal and/or written instructions required.\nAbility to understand and articulate how individual role and responsibilities tie into Quality department function, goals and objectives\nWork Environment\nWorks in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.\nAbility to regularly lift up to 30 lbs with repetitive movements.\nAbility to push and pull items.\nAbility to stand, sit, walk up to 80% of a shift.\nAbility to travel between office and production departments as well as company buildings required.\nUp to 25% travel required (some international)\n Why Join Nemera?\nAt Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.\nWe look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net\nKnow someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!\nPAY RANGE: $85,000 - $105,000 USD Salaried (This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.)\nFor US Benefits, CLICK HERE.\nNemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.","description_format":"text","description_chars":7002,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Germany","iso":"DE","kind":"country"},{"name":"France","iso":"FR","kind":"country"},{"name":"Brazil","iso":"BR","kind":"country"},{"name":"Poland","iso":"PL","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-13T15:02:30Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3 · green card filings: 1","filings_12m":3,"filings_prev_12m":2,"green_card_filings_12m":1,"median_offered_wage_usd":107500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":44,"reasons":["conf:3","win:early"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/nemera-quality-validation-engineer-equipment-validation","json_url":"https://alion.io/job/nemera-quality-validation-engineer-equipment-validation.json","meta":{"generated_at":"2026-10-14T11:21:48Z","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":13558,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":690405},"rest":"https://alion.io/mcp/rest/get_company?id=690405"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnemera-quality-validation-engineer-equipment-validation"},{"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%2Fnemera-quality-validation-engineer-equipment-validation"},{"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%2Fnemera-quality-validation-engineer-equipment-validation"},{"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/nemera-quality-validation-engineer-equipment-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnemera-quality-validation-engineer-equipment-validation"}]}