Computer Systems Validation (CSV) Engineer

Watchmaker Genomics•Boulder, CO, CO

5h•$120,000 - $130,000•Onsite

About The Position

Watchmaker Genomics is hiring a full-time, permanent, onsite Computer Systems Validation (CSV) Engineer in Boulder, Colorado. Reporting to the Director of IT, Boulder, this role leads end-to-end validation of computerized systems and performs day-to-day design, creation, and execution of validation protocols, test scripts, change management, and end-user training. The engineer also helps create processes and documentation supporting computer systems validation, including materials related to ISO 13485:2016, GxP, and 21 CFR Part 11, such as plans, user requirements specifications, assessments, and summary reports. The role manages validation across laboratory, manufacturing, and cloud-based applications in a dynamic, fast-paced genomics and life sciences environment. It works across IT, Quality Assurance, Product Development, Operations, and R&D, and includes mentoring junior CSV team members, supporting audits and inspections, maintaining compliance and data integrity, and keeping validation documentation inspection-ready. The position may involve managing multiple validation projects and reprioritizing in response to audit schedules, implementation timelines, or regulatory requirements. The budgeted salary range is $120,000–$130,000, plus bonus and equity, with actual pay adjusted based on skills and experience. Benefits include Flexible Time Off, holidays, medical coverage with the employer covering 75% of the base plan, EAP, employer-paid dental and vision coverage, an employer-paid $25,000 life/AD&D policy, paid parental leave, and a 401(k) plan with a 4% match.

Requirements

At least 5 years of CSV experience in a regulated environment such as biotechnology, pharmaceuticals, or medical devices.
Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related discipline, with 5+ years of CSV experience in a GxP-regulated environment; candidates without a bachelor’s degree may qualify with commensurate experience (the posting gives AS plus 7 years or no degree plus 9 years in its position details).
Alternatively, 7+ years of relevant CSV experience in a GxP-regulated biotechnology or pharmaceutical environment without a formal degree, with equivalent knowledge and competency.
Proven experience authoring and executing IQ/OQ/PQ protocols for a range of system types.
Strong working knowledge of ISO 13485, 21 CFR Part 11, and data integrity principles.
Demonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously.
Experience supporting internal and external regulatory audits and inspections as a CSV subject matter expert.
Experience authoring and reviewing CSV SOPs, work instructions, and validation templates.
Strong interpersonal skills and ability to work effectively as a team member.
Ability to mentor and guide junior engineers and promote best practices and effective collaboration.
Excellent organizational and time-management skills, including the ability to work accurately under time pressure and make sound regulatory judgments.
Ability to work onsite in Boulder; local candidates are preferred.

Nice To Haves

Experience in multinational or corporate environments (described as essential in the posting’s preferred-experience section).
Experience with CSV for laboratory equipment qualification and computerized laboratory systems.
Familiarity with GxP IT infrastructure, including IQ/OQ of servers, networks, and virtualized environments.
Experience with CSV for cloud-based SaaS applications in regulated environments.
Familiarity with standards and regulations such as ISO, POPIA, GDPR, or HIPAA as they relate to data integrity and systems compliance.

Responsibilities

Lead planning, authoring, execution, and review of validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.
Manage the full lifecycle of assigned laboratory, manufacturing, and cloud-based systems.
Compile validation summary reports and obtain required approvals before systems enter operational use.
Apply risk-based validation and testing methods proportionate to system risk and complexity; document decisions and rationale.
Collaborate with IT, QA, Product Development, Operations, and R&D to gather requirements, support implementation, and ensure validation readiness.
Translate operational, laboratory, and manufacturing needs into validation strategies and deliverables.
Align local execution with the validation framework and program priorities in partnership with IT Directors and future CSV team leadership.
Mentor junior CSV team members, provide technical guidance, share knowledge, and contribute review feedback.
Support recruitment and onboarding of CSV team members as requested.
Perform risk assessments using approved methodology and apply risk-based testing across IQ, OQ, and PQ.
Manage and document change controls for validated systems, assess changes, update validation documentation, and ensure changes comply with regulatory and QMS requirements.
Conduct periodic reviews of validated systems to confirm continued compliance and fitness for purpose.
Lead CSV response activities during system incidents or unplanned changes affecting validated environments.
Identify, document, and manage deviations, CAPAs, and change controls; coordinate remediation with IT, QA, and business stakeholders and communicate status.
Validate and monitor cloud-based GxP applications, review configurations and access controls, and partner with IT on infrastructure changes that may affect validated environments.
Author and review CSV SOPs, work instructions, and standard templates; maintain documentation and traceability across requirements, tests, and evidence.
Ensure documentation meets QMS and regulatory expectations and is ready for audit.
Ensure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs; monitor data integrity and escalate or remediate issues with QA.
Maintain alignment with ISO 13485 for in-scope systems and support QMS-driven activities.
Serve as CSV subject matter expert during internal audits and external regulatory inspections; prepare validation evidence and respond to findings through CAPA.
Monitor regulatory and industry guidance changes, assess their impact on validated systems, and apply emerging best practices.
Manage multiple validation projects and reprioritize based on audits, implementation schedules, and regulatory requirements.