Computer Systems Validation (CSV) Engineer (Life Sciences)

Location: Boulder, Colorado; onsite. Local candidates preferred. Applicants will be asked about current US work eligibility and future visa sponsorship requirements.

Salary: $120,000–$130,000 annually, plus bonus and equity.

Company

hirify.global operates in genomics and life sciences, supporting regulated computerized systems and compliance activities.

What you will do

• Lead planning, authoring, execution, review, and approval of CSV documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols.
• Manage validation lifecycles for laboratory, manufacturing, and cloud-based applications using risk-based methodologies.
• Coordinate requirements, implementation readiness, change controls, periodic reviews, incidents, deviations, CAPAs, and remediation with IT, QA, Product Development, Operations, and R&D.
• Validate cloud GxP applications, review configurations and access controls, and maintain traceability across requirements, tests, and evidence.
• Author and maintain CSV SOPs, work instructions, templates, summary reports, and audit-ready documentation.
• Mentor junior CSV team members, provide technical guidance, and support recruitment and onboarding as requested.

Requirements

• At least 5 years of CSV experience in a regulated biotech, pharmaceutical, medical-device, or comparable GxP environment.
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related discipline; candidates without a bachelor’s degree may qualify with AS plus 7 years or no degree plus 9 years of commensurate experience.
• Proven experience authoring and executing IQ/OQ/PQ protocols for multiple system types and managing the full CSV lifecycle for several systems simultaneously.
• Strong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles, applicable SOPs, and QMS requirements.
• Experience supporting internal and external regulatory audits and inspections as a CSV subject matter expert.
• Experience authoring and reviewing CSV SOPs, work instructions, validation templates, assessments, and summary reports.
• Strong interpersonal, organizational, time-management, and prioritization skills for a dynamic, compliance-critical environment.
• Proven ability to mentor and guide junior engineers and collaborate effectively across functions.
• Onsite work in Boulder is required; local candidates are preferred.

Nice to have

• Experience in multinational or corporate environments.
• Experience qualifying laboratory equipment 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 they apply to data integrity and systems compliance.

Culture & Benefits

• Full-time, permanent role in a dynamic, fast-paced genomics and life sciences environment.
• Work includes compliance-critical decisions, rigorous documentation, multiple concurrent validation projects, and reprioritization based on audits, implementations, and regulatory requirements.
• Flexible Time Off, holidays, and paid parental leave.
• Employer-paid or partially paid medical, dental, vision, life, and AD&D coverage, including 75% of the base medical plan and a $25,000 life/AD&D policy.
• Employee assistance program and 401(k) plan with a 4% employer match.

Hiring process

• Submit a PDF application through watchmakergenomics.com with a letter of motivation and a resume or CV highlighting relevant qualifications and experience.
• Applications without a letter of motivation will not be considered. Applications are reviewed on a rolling basis until the position is filled.
• Selected candidates must provide the names and contact information of three professional references; pre-employment checks may include driving history, drug screening, and a background check.