{"id":3712642,"url":"https://alion.io/job/watchmaker-genomics-computer-systems-validation-csv-engineer","title":"Computer Systems Validation (CSV) Engineer","company":{"id":688554,"name":"Watchmaker Genomics","domain":"watchmakergenomics.com","url":"https://alion.io/company/watchmakergenomics","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Boulder, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GDPR","optional":false},{"name":"HIPAA","optional":false},{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2026-11-03T19:46:22Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-07T03:11:34Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Position: Computer Systems Validation (CSV) Engineer\nPosition Type: Full-time, permanent\nDepartment: Information Technology (IT)\nLocation: Boulder, onsite\nExperience: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline and 5+ years CSV experience in a GxP-regulated environment. Will consider those without a Bachelors with commensurate experience (AS+7 years or no degree+9 years). \nPosition Summary\nWatchmaker Genomics is inviting applications for the full-time Computer Systems Validation (CSV) Engineer position, an on-site role in Boulder, Colorado. This position reports to the Director of IT, Boulder, and is responsible for leading the end-to-end validation of computerized systems within the environment. This position will perform day-to-day tasks related to the design, creation, and execution of validation protocols, test scripts, change management, and end-user training activities. \nAdditionally, this position is expected to assist in creating new processes, ISO 13485:2016, GxP, and 21 CFR Part 11-related documentation to support and maintain the organization's computer systems validation efforts. This may include, but not be limited to, plans, URS documentation, assessments, and summary reports.\nThe successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and compliance posture. This position will offer unique challenges, learning, and growth in a cutting-edge genomics and life sciences environment.\nResponsibilities\nCore Responsibilities\nValidation Lifecycle & Delivery\nLead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.\nManage the full lifecycle of assigned systems, including laboratory, manufacturing, and cloud-based applications.\nCompile validation summary reports and secure required approvals for systems entering operational use.\nApply risk-based validation methodology to scope effort proportionate to system risk and complexity.\nCross-Functional Collaboration\nCollaborate with IT, QA, Product Development, Operations, and R&D stakeholders to gather requirements, support implementation, and ensure validation readiness.\nTranslate operational, laboratory, and manufacturing needs into validation strategy and deliverables.\nPartner with IT Directors (and future CSV Manager and Principal CSV Engineer) to align local execution with the validation framework and programme priorities.\nTechnical Leadership & Mentoring\nMentor junior CSV team members and provide technical guidance on CSV best practices.\nContribute to internal CSV capability uplift through knowledge sharing and review feedback.\nSupport recruitment and onboarding activities for new CSV team members as requested.\nTechnical Operations & Validation\nRisk-Based Validation\nPerform risk assessments using approved methodology and apply a risk-based approach to all CSV activities.\nDocument risk decisions and validation rationale to provide defensible audit evidence.\nApply risk-based testing strategies across IQ, OQ, and PQ activities.\nChange Control & Periodic Review\nManage and document change controls for validated systems, ensuring all changes are assessed, approved, and implemented in line with regulatory and Quality Management System (QMS) requirements.\nConduct periodic reviews of validated systems to confirm continued compliance and fitness for purpose.\nUpdate validation documentation following approved changes to assigned systems.\nIncident Response & Deviation Management\nLead CSV response activities during system incidents or unplanned changes affecting validated environments.\nIdentify, document, and manage deviations, CAPAs, and change controls related to validated systems.\nCoordinate remediation actions with IT, QA, and business stakeholders, and communicate status throughout.\nCloud-Based System Validation\nValidate and monitor cloud-based GxP applications in line with regulatory expectations.\nReview cloud system configurations and access controls regularly to maintain a validated state.\nPartner with IT on cloud infrastructure changes that may impact validated environments.\nSOPs & Validation Documentation\nAuthor and review CSV SOPs, work instructions, and standard templates.\nMaintain validation documentation and traceability across requirements, tests, and evidence.\nEnsure documentation meets QMS and regulatory expectations for audit readiness.\nCompliance, Risk & Quality Assurance\nRegulatory Compliance & Data Integrity\nEnsure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs.\nMonitor validated systems for data integrity adherence, escalate, and remediate issues with QA.\nMaintain alignment with ISO 13485 for in-scope systems and support QMS-driven activities.\nAudit & Inspection Support\nServe as CSV subject matter expert during internal audits and external regulatory inspections for assigned systems.\nPrepare inspection-ready validation evidence and respond to findings through CAPA.\nProvide a defensible regulatory rationale for validation decisions and approach.\nRegulatory Intelligence Application\nMonitor changes in regulatory requirements and industry guidance and assess their impact on validated systems.\nApply emerging best practice and guidance to ongoing validation activities.\nSkills and Requirements \nMinimum 5 years of experience in CSV within a regulated environment (biotech, pharma, or medical devices);\nProven experience authoring and executing IQ/OQ/PQ protocols for a range of system types;\nStrong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles;\nDemonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously;\nExperience supporting internal and external regulatory audits and inspections as a CSV subject matter expert;\nExperience authoring and reviewing CSV SOPs, work instructions, and validation templates;\nStrong interpersonal skills and an ability to work as an effective member of a team;\nProven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.\nPreferred Additional Experience:\nExperience in multi-national or corporate environments is essential;\nExperience with CSV for laboratory equipment qualification and computerized laboratory systems;\nFamiliarity with IT infrastructure in a GxP context, including IQ/OQ of servers, networks, and virtualized environments;\nExperience with CSV for cloud-based SaaS applications in regulated environments;\nFamiliarity with industry standards and regulations such as ISO, POPIA, GDPR, or HIPAA as they apply to data integrity and systems compliance;\nEducation and Experience\nBachelor’s degree in Computer Science, Engineering, or a related field, with a minimum of 5 years’ CSV experience in a GxP-regulated environment, or\n7+ years of relevant CSV experience in a GxP-regulated biotech or pharmaceutical environment, without a formal degree requirement, provided the candidate can demonstrate equivalent knowledge and competency.\nEnvironmental Conditions: Successful candidate(s) may need to manage multiple validation projects simultaneously and may be required to reprioritize based on audit schedules, system implementation timelines, or regulatory requirements. The environment is dynamic and fast-paced, requiring excellent organizational and time management skills.\nMental Demands: Successful candidate(s) will work in a compliance-critical environment where accuracy, rigor, and sound regulatory judgment are essential. The role requires maintaining high standards of documentation quality under time pressure and making well-reasoned decisions on complex validation matters.\nCompensation\nThe budgeted range for this position starts at $120,000 - $130,000 + bonus + equity; actual pay will be adjusted based on skills and experience. Employees are eligible for Flexible Time Off, Holidays, employer covers 75% of base medical plan with buy-up options, EAP (employee assistance program), employer paid dental with a buy-up option, employer paid vision, employer paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) retirement plan with a 4% match.\nApplication Requirements\nTo apply for the position, please submit the following in a PDF format on watchmakergenomics.com: \nLetter of motivation (upload where it says cover letter)\nResume or Curriculum vitae, highlighting relevant qualifications and experience\nApplications without a Letter of Motivation will not be considered. Local candidates preferred.\nApplications will be accepted on a rolling basis and the position will remain open until filled; however, early submission is encouraged as review will begin immediately.\nIf selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.\n*** WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER\nWatchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.\nAll applicants will be asked if currently eligible to work in the United States of America; and if now or in the future will require visa sponsorship to continue working in the United States.\nThis position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. 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