Remote-Eligible Senior Computer Systems Validation Analyst

Jobgether; United States; Remote; USD 120,000 - 135,000; Full time

Benefits offered by this job

Competitive salary: $120,000–$135,000

Remote work in the United States

Professional development

Collaborative environment

Inclusive workplace

Workplace accommodations

Job summary

Jobgether in the United States lists a Computer Systems Validation Analyst II on behalf of a partner company in biotech. The role focuses on validating computerized systems across labs, manufacturing, and enterprise operations, ensuring 21 CFR Part 11 and ALCOA+ data integrity.

You will develop validation documentation, manage lifecycle, coordinate cross-functional teams, and apply Agile, Waterfall, and hybrid SDLC approaches while delivering compliant, well-documented systems in a fast-paced

Qualifications

• Bachelor's degree or equivalent in a relevant technical field.
• At least five years of experience in computer systems validation in regulated environments.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+.
• Experience with validation documentation and risk assessments.
• Experience supporting laboratory, manufacturing, or enterprise applications across sites.
• Proven ability to manage multiple validation projects and deadlines.

Responsibilities

• Manage the computer systems validation lifecycle from planning to final compliance review.
• Ensure regulatory compliance and data integrity across systems.
• Develop validation documents: plans, requirements, test scripts, traceability.
• Collaborate with labs, IT, and enterprise teams to validate systems.
• Coordinate project execution, track milestones, and manage dependencies.
• Handle change controls and periodic reviews to maintain compliance.
• Apply SDLC methodologies (Agile, Waterfall, hybrid) to validation activities.
• Investigate issues and coordinate with stakeholders for resolution.
• Maintain quality through documented policies and procedures.

Skills

Regulatory compliance

Validation lifecycle

Documentation & traceability

Agile/Waterfall/Hybrid SDLC

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Information Technology, Life Sciences, Engineering, or another relevant technical discipline

Job description

Jobgether in the United States lists a Computer Systems Validation Analyst II on behalf of a partner company in biotech. The role focuses on validating computerized systems across labs, manufacturing, and enterprise operations, ensuring 21 CFR Part 11 and ALCOA+ data integrity.

You will develop validation documentation, manage lifecycle, coordinate cross-functional teams, and apply Agile, Waterfall, and hybrid SDLC approaches while delivering compliant, well-documented systems in a fast-paced