Computer Systems Validation (CSV) Engineer

Watchmaker Genomics•Boulder, CO

4d•Onsite

About The Position

Watchmaker Genomics is hiring a full-time, permanent Computer Systems Validation (CSV) Engineer for an onsite position in Boulder, Colorado. Reporting to the Director of IT, Boulder, the engineer leads end-to-end validation of computerized systems and performs day-to-day work involving validation protocol design, creation and execution, change management, and end-user training. The role also helps create processes and documentation related to ISO 13485:2016, GxP, and 21 CFR Part 11, including plans, user requirements specifications, assessments, and summary reports. The engineer manages validation across laboratory, manufacturing, and cloud-based applications, applying risk-based methods and maintaining systems in a compliant, inspection-ready state. The position collaborates with IT, QA, Product Development, Operations, and R&D; provides technical guidance and mentoring to junior CSV team members; and supports audit and regulatory inspection activities. Work takes place in a dynamic, fast-paced genomics and life sciences environment, where multiple validation projects may need to be managed and reprioritized. Accuracy, documentation rigor, organizational skills, and sound regulatory judgment are essential.

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 equivalent experience (associate degree plus 7 years, or no degree plus 9 years).
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 part of a team.
Proven ability to mentor and guide junior engineers and promote best practices and collaboration.
Ability to manage multiple validation projects and reprioritize in response to audit schedules, system implementation timelines, or regulatory requirements.
Excellent organizational and time-management skills, accuracy, documentation rigor, and sound regulatory judgment.

Nice To Haves

Experience in multinational or corporate environments.
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 validating cloud-based SaaS applications in regulated environments.
Familiarity with ISO, POPIA, GDPR, or HIPAA as applicable to data integrity and systems compliance.
Local candidates preferred.

Responsibilities

Lead the planning, authoring, execution, and review of validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.
Manage the full validation lifecycle for assigned laboratory, manufacturing, and cloud-based applications.
Compile validation summary reports and obtain required approvals before systems enter operational use.
Apply risk-based validation and testing approaches proportionate to system risk and complexity; document risk 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 leadership and CSV colleagues.
Mentor junior CSV team members, provide technical guidance, share knowledge, review work, and support recruitment and onboarding as requested.
Manage and document change controls for validated systems, assess changes, and update validation documentation following approved changes.
Conduct periodic reviews of validated systems to confirm continued compliance and fitness for purpose.
Lead CSV response activities during incidents and unplanned changes affecting validated environments; 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 affecting validated environments.
Author and review CSV SOPs, work instructions, and templates; maintain documentation and traceability across requirements, tests, and evidence.
Ensure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, applicable SOPs, and QMS requirements.
Monitor systems for data integrity adherence, escalate and remediate issues with QA, and support QMS-driven activities.
Serve as CSV subject matter expert during internal audits and external regulatory inspections; prepare evidence and respond to findings through CAPA.
Monitor regulatory and industry guidance changes, assess their impact on validated systems, and apply emerging best practices.