{"id":4072522,"url":"https://alion.io/job/instem-validation-engineer","title":"Validation Engineer","company":{"id":2133524,"name":"Instem","domain":"instem.com","url":"https://alion.io/company/instem-com","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Cornerstone","truth_index":{"grade":"B","score":81,"open_postings":8,"ghost_share":0,"stale_share":0.75,"repost_share":0,"time_to_fill_p50_days":25,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Conshohocken, United States"],"countries":["US"],"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":[{"name":"21 CFR Part 11","optional":false},{"name":"AWS","optional":false},{"name":"Azure DevOps","optional":false},{"name":"GMP","optional":false},{"name":"Playwright","optional":false},{"name":"PowerShell","optional":false},{"name":"Python","optional":false},{"name":"SAS","optional":false},{"name":"Selenium","optional":false},{"name":"Azure","optional":true},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-11-11T12:00:00Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-12T01:26:31Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Validation Engineer Location: Hybrid/Remote: The successful candidate can work on a Hybrid/Remote basis, reporting into one of our offices located in Pennsylvania or North Carolina. Status: Permanent Package: Competitive Salary, Remote/Home Working (with one-off allowance), Flexible Working, (2 Days in the office for our Hybrid workers) Development Opportunity (Personal Technical), Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Long Term Short-Term Disability Insurance, Generous 401K (matching) Plan, Flexible Spending Account, Health Savings Account, 15 Days' Vacation + Plus Public Holidays + Buy and Sell Scheme. d-wise, an Instem company, designs, deploys, and supports validated cloud infrastructure for life-sciences and clinical trial organizations. Our flagship product, Accel, is a turn-key, validated Statistical Computing Environment (SCE) built on AWS and pre-loaded with SAS, R, Python, and Posit tools; giving biostatisticians and clinical programmers a secure, compliant, and high-performance environment for clinical data analysis and regulatory submission. The Validation Engineer provides validation and compliance services to internal and external clients, ensuring that Instem software and systems meet regulatory requirements and industry standards. The role delivers validation activities across multiple projects, from technical advice, audits and requirements and risk assessments through to test execution. It also plays an active part in shaping how Instem performs validation, championing risk-based approaches and identifying and implementing opportunities to automate validation testing and improve efficiency. Our Culture Work Environment. You’ll be part of a friendly, solutions-focused environment within a global business of over 400 people. Here, you’ll experience a high-performance culture balanced with genuine flexibility - we trust you to take ownership, deliver meaningful results, and work in a way that suits you. You’ll be encouraged to grow, share your ideas, and make a real impact. We’re passionate about creating a place where you can develop your skills, contribute confidently, and succeed in your career. Why join us as a Validation Engineer? This role is an opportunity for you to shape how we do validation here at Instem, if you are looking for a role where you can shape, define and change processes in validation, this could be a perfect role for you! What You’ll Be Doing Validation Activities:\nValidation exercises for internal and external clients: o Planning: Documenting the stages and content of the exercise. o Organizing remote system access. o Assessing risks and advising on mitigation activities. o Execution: Producing documentary evidence that fulfils the planned requirements, including regulatory-acceptable execution of manual and automated tests. o Reporting: Documenting the executed activities, summarizing findings and advising on next steps.\nDetailed fault/deviation analysis and resolution planning.\nFacilitation of Change/Risk Assessment and other validation support activities.\nSupport the resourcing and scheduling of validation projects and activities.\nMaintenance of Work Instructions for identified processes and tools. Validation Approach Definition:\nHelp define and evolve Instem’s validation methodology and standards, including risk-based approaches aligned with current industry guidance.\nIdentify validation activities suitable for automation, prioritizing by feasibility, effort and expected benefit.\nDesign, develop and maintain automated validation tests and frameworks that remain fit for purpose in a GxP context (e.g. tool assurance, evidence capture, data integrity).\nAnalyze validation processes and deliverables to remove bottlenecks, duplication and rework, using measures such as cycle time, effort and deviation rates to demonstrate impact.\nWork with Development, QA and Product teams to align validation with the software development lifecycle, leveraging existing development testing where appropriate.\nPilot new tools and techniques and support their adoption across the team through guidance and training. Documentation Reporting:\nCreation of “typical workflow” diagrams or documentation to support requirements analysis.\nDevelopment, maintenance and review of client-facing UAT test scripts.\nCreation and maintenance of Test Evidence packages, including analysis of content extracted from Azure DevOps, automating their production where possible.\nCreation and maintenance of source material and templates in Instem’s Document Management System.\nReview updated Validation Support Package materials for content, coverage, accuracy and formatting against product functionality, system specifications and client requirements. Client Support:\nCollaborate with internal teams and clients to understand validation requirements and advise on efficient, risk-based approaches, including how automation and Instem’s validation materials can reduce their effort.\nParticipate in client meetings and audits as needed. Compliance Quality:\nStay current with regulatory requirements, industry trends and best practice in validation and quality assurance.\nChampion continuous improvement, ensuring changes to validation methods remain compliant and are documented, reviewed and approved.\nAdherence to the Company’s Quality Management System to ensure that all work is handled Securely, Professionally and Diligently. What We’re Looking For\nExperience in the validation of computer and software systems within a GxP environment\nKnowledge of industry standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, etc…\nExperience with test automation tools (e.g. Selenium, Playwright) and/or scripting (e.g. Python, PowerShell) is a plus\nFamiliarity with Azure DevOps or similar application lifecycle management tools\nDemonstrable experience of process improvement, ideally in a regulated environment\nGood knowledge of Microsoft Office products Ready to Make a Difference? Join a team that values your perspective and supports your growth, while helping shape the future of life sciences. Apply now - we’d love to hear from you, and our Talent team will be in touch. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/ #LI-KL #LI-HYBRID","description_format":"text","description_chars":6670,"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":[]},"benefits":["401k plan","Dental insurance","Flexible schedule","Health insurance","Life insurance","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Scientific & Lab Software"],"lifecycle":[{"event":"open","at":"2026-11-11T14:03:41Z"}],"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":25,"reasons":["conf:0","win:early"],"computed_at":"2026-11-12T01:36:06Z"},"pay":null,"html_url":"https://alion.io/job/instem-validation-engineer","json_url":"https://alion.io/job/instem-validation-engineer.json","meta":{"generated_at":"2026-11-12T01:36:06Z","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":3689,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"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":2133524},"rest":"https://alion.io/mcp/rest/get_company?id=2133524"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Finstem-validation-engineer"},{"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%2Finstem-validation-engineer"},{"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%2Finstem-validation-engineer"},{"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/instem-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Finstem-validation-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4072522}},{"tool":"search_jobs","arguments":{"company":"instem.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4072522},"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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