{"id":3472853,"url":"https://alion.io/job/medline-sr-engineer-software-validation-2","title":"Sr Engineer Software Validation","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":98,"ghost_share":0,"stale_share":0.663,"repost_share":0.031,"time_to_fill_p50_days":31,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Backend","role_family":"Backend","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":101000,"max":152000,"currency":"USD","period":"year","gross":null,"usd_annual":152000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"21 CFR Part 820","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Kanban","optional":false}],"status":"live","first_seen_at":"2026-10-27T00:00:00Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-29T23:04:43Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Summary\nDeliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner.Job Description\nMAJOR RESPONSIBILITIES:\nEvaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations.\nEnsure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements.\nManage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer informed and satisfied.\nDocument validation protocols and reports with professional and technical written communication skills.\nKnow, support, and conform to Medline policies and relevant governing procedures.\nMaintain awareness to industry and regulatory environment, including FDA, GAMP, ISO.\nMaintain organizational excellence, including document control, quality records, detail, and thoroughness.\nEvaluate ways to streamline and improve efficiencies in software validation and associated processes.\nProvide team support in all validation initiatives as requested. Support division facilities on-site when needed.\nMINIMUM JOB REQUIREMENTS:\nEducation:\nBachelor’s degree in Engineering, Quality, Business, or Computer Science.\nWork Experience:\nAt least 5 years of experience in Manufacturing, Quality or Engineering.\nAt least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating.\nDirect experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures.\nKnowledge / Skills / Abilities:\nExperience applying knowledge of standard concepts, practices, and procedures within software engineering.\nExperience and skills in influencing, leading and directing individuals in multiple functional areas.\nExperience with project management (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives).\nExperience working in an AS400 environment.\nPosition requires travel up to 25% of the time for business purposes (within state and out of state).\nPREFERRED JOB REQUIREMENTS:\nWork Experience:\nExperience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).\nExperience with the following:\nQMS - ISO13485:2016\n21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling\nGAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5)\nISO / Customer / Regulator Audits\nFDA Product and Establishment Registration\nGS1 / GUDID Management\nQuality Management System / Medical device environment experience.\nKnowledge / Skills / Abilities:\nProficient in MS Word, Project, Excel.\nExperience in people and process management.\nContinuous improvement and Kanban related project experience\nMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.\nThe anticipated salary range for this position:\n$101,000.00 - $152,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.\nOur benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.\nWe’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.\nMedline Industries, LP is an equal opportunity employer. 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