{"id":3826961,"url":"https://alion.io/job/getinge-engineer-i-controlled-environments","title":"Engineer I, Controlled Environments","company":{"id":719311,"name":"Getinge","domain":"getinge.com","url":"https://alion.io/company/getinge-2","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":13,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Merrimack, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"EU MDR","optional":false}],"status":"live","first_seen_at":"2026-11-05T18:45:45Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-07T02:01:16Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"With a passion for life\nJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.\nAre you looking for an inspiring career? You just found it.\n\nJob Overview\nA Quality Engineer I, Controlled Environments, is responsible to provide engineering and technical support in the areas of Cleanroom Environmental Monitoring, Contamination Controls, and Microbiological Testing. This includes development, revision, organization, administration, and compliance of the company’s routine Controlled Environment efficacy programs including Systems Qualification, Environmental Monitoring, and Biological Product Testing. A Quality Engineer, Controlled Environments, shall also perform tasks, as assigned, to support change control, CAPA activities, and other compliance activities related to the Controlled Environment and Contamination Control Programs.\nJob Responsibilities and Essential Duties\nDevelopment, qualification, maintenance, and nonconformance analysis of a routine testing program for maintenance of a manufacturing environment suitable for the manufacture of medical devices. The program includes, but is not limited to, the following tests:\nAir pressure differential measurement\nTemperature and %RH measurement (where applicable)\nAir Particulate Testing\nMicrobiological tests of system and testing waters\nBiological Air Testing\nBioburden analysis (surface)\nCompressed Air and Nitrogen Testing.\nMicrobiological Testing as part of the sterilization assurance and contamination control program also include the following:\nBacterial Endotoxin analysis of finished goods and in in-process components.\nBioburden analysis (finished goods)\nOversee and/or perform sampling for aforementioned test types as required.\nOversee, perform and/or review controlled environment and microbiological test result data entry.\nMaintenance of contamination control, environmental monitoring, and bacterial endotoxin risk assessments.\nEnsure continued conformance to existing standards (e.g. ISO 14644 series, ISO 11737-1, and ANSI/AAMI ST72), perform gap analysis for new/revised standards/guidance documents, and maintain compliance by implementing changes to conform (where applicable) to conform to new/revised industry standards.\nRepresenting CE&S for Operations projects working towards optimizing the manufacturing workflow including equipment and work stream relocations.\nRepresenting CE&S in cross functional project teams working towards introducing new products lines or expanding existing lines.\nDevelopment of Controlled Environment IQ/OQ/PQ protocols and reports to support facility and operation changes.\nMaintenance of Controlled Environment Requalification Program, including generation of protocols/reports. \nGeneration and ownership of Controlled Environment, Contamination Control and Microbiological Testing CAPA Requests and CAPAs\nRepresenting CE&S in cross function CAPAs where necessary. \nPerformance and/or supervision of additional departmental analysis, or tasks, including, but not limited to:Writing, implementing, revising, and, or approving Standard Procedures (SPs), protocols, and reports relating to Controlled Environments.\nAuthoring, ensuring execution of and approving microbiological test method validations.\nGenerating Controlled Environment & Microbiological related content and controls within equipment relocation plans, part qualification, supplier change assessments, and design change quality plans.\nNonconformance technical support for controlled environment and product testing excursion events including root cause analysis and investigation.\n\nDevelopment, maintenance, and execution of Environmental and Product Microbiological Testing Trend Analysis Programs\nAdditional projects as assigned by Departmental Management.\nAssists in special projects as needed.\nContributes to team effort by accomplishing related duties as requested.\n\nMinimum Requirements\nA Bachelors’ Degree in Engineering, Biology, Microbiology, Chemistry, or a related science and two years’ experience in a medical device or pharmaceutical environment. \nEquivalent work experience shall be acceptable in place of education at the discretion of the Manager, CE&S. \nRequired Knowledge, Skills and Abilities\nHighly organized with strong negotiation and communication skills.\nDetail oriented with ability to self review\nFamiliarity with ISO Standards for Controlled Environments and Microbiological Testing\nAbility to create and revise technical documentation as well as author position pieces with minimal guidance\nSupervision/Management OfOthers:\nN/A\nInternal and External Contacts/Relationships\nVarious\nQuality Requirements\nBuild Quality into all aspects of their work by maintaining compliance to all quality requirements.\n Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).\n Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).\nAttend all required Quality & Compliance training at the specified interval.\nAdopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.\nEnvironmental/Safety/Physical Work Conditions\nEnsures environmental consciousness and safe practices are exhibited in decisions.\nDuties are performed in an office environment.\nDuties are performed in a manufacturing/clean room environment. \nPersonal protective equipment may be required as dictated by work environment. \nSome duties may be performed remotely.\n\nAbout us\nWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.\nBenefits at Getinge:\nAt Getinge, we offer a comprehensive benefits package, which includes:\nHealth, Dental, and Vision insurance benefits\n401k plan with company match\nPaid Time Off\nWellness initiative & Health Assistance Resources\nLife Insurance\nShort and Long Term Disability Benefits\nHealth and Dependent Care Flexible Spending Accounts\nCommuter Benefits\nParental and Caregiver Leave\nTuition Reimbursement\nGetinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. 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