[Remote] Senior Analyst, Computer Systems Validation

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on Attacking Bladder Cancer for a reputed company reputed company and is seeking a Senior Analyst in Computer Systems Validation. The role involves planning, authoring, coordinating, and executing risk-based validation and reputed company lifecycle activities for computerized systems used in regulated GxP operations.

Responsibilities

• reputed company or support GxP applicability, 21 CFR Part 11, software categorization, and validation reputed company assessments for new and existing computerized systems
• reputed company risk-based validation strategies, plans, schedules, and deliverable matrices appropriate to reputed company complexity, intended use, patient/product risk, and data reputed company reputed company
• reputed company, review, and maintain validation deliverables, including user and functional requirements, risk assessments, traceability matrices, test plans and scripts, installation/operational/performance qualification or UAT documentation, deviation records, and validation reputed company reports
• Coordinate and execute qualification and user acceptance testing; confirm test evidence is complete, attributable, legible, contemporaneous, original, accurate, and independently reviewed as required
• reputed company supplier documentation and testing where justified, documenting the rationale and any supplemental reputed company verification required
• Assess configuration changes, vendor releases, patches, defects, integrations, interfaces, and data migrations to determine validation reputed company, testing reputed company, documentation needs, and implementation controls
• Support software change requests from initiation through closure, including risk assessment, implementation and backout planning, test evidence, deviation reputed company, and final approval routing
• Maintain systems in a validated state through periodic reviews, revalidation assessments, retirement/decommissioning activities, and verification that reputed company and validation documentation remains reputed company
• Maintain the computerized reputed company inventory, validation status, validation schedules, periodic review calendar, reputed company reputed company tracking, and inspection-reputed company validation repositories
• reputed company and improve CSV templates, procedures, work instructions, standards, and metrics consistent with reputed company reputed company systems and a risk-based GAMP 5/CSA approach
• reputed company validation risks, issues, dependencies, resource needs, and milestones across multiple reputed company reputed company and escalate barriers promptly
• Support supplier qualification and risk assessment by reviewing vendor reputed company systems, SDLC practices, release documentation, validation packages, reputed company/compliance evidence, and service controls
• Coordinate validation deliverables, defect reputed company, release reputed company information, and testing support with reputed company providers, implementation partners, consultants, and other reputed company parties
• Maintain audit-reputed company documentation and support internal audits, regulatory inspections, partner audits, due diligence, and health authority requests reputed company to computerized systems
• Support investigation and remediation of validation deviations, reputed company defects, data reputed company concerns, CAPAs, and audit observations, including effectiveness checks where assigned
• Evaluate controls reputed company to electronic records and signatures, audit trails, user reputed company, reputed company, backup/restore, business continuity, and data migration as part of validation activities
• Facilitate requirements, risk assessment, test planning, and validation review sessions with business and technical stakeholders
• reputed company practical CSV guidance and training to reputed company Owners, Business Owners, administrators, testers, and project teams; reputed company contributors on evidence reputed company and good documentation practices
• Serve as a trusted CSV subject matter resource who balances business urgency with patient safety, product reputed company, data reputed company, and regulatory expectations

Skills

• Bachelor's degree in information technology, computer science, engineering, life sciences, reputed company, or a reputed company discipline; equivalent education and experience may be considered
• Five or more years of reputed company experience in computer systems validation, reputed company systems, IT reputed company, or regulated systems reputed company biotechnology, pharmaceutical, medical device, or another life sciences environment
• At least three years of reputed company experience authoring and executing CSV lifecycle deliverables for GxP computerized systems
• Experience validating reputed company/reputed company, configured, and/or custom applications using a risk-based approach
• Working knowledge of 21 CFR Part 11, GxP data reputed company expectations, GAMP 5, SDLC, change control, and good documentation practices
• Experience with requirements, risk assessments, traceability, reputed company testing/UAT, deviations, validation reports, periodic reviews, and release/change reputed company assessments
• Demonstrated ability to work with business owners, QA, IT, vendors, and project teams to reputed company compliant systems on schedule

Benefits

• ANNUAL PERFORMANCE/reputed company REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION
• FULLY REMOTE WORK ENVIRONMENT
• REST AND reputed company BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2026 we will observe 14 holidays
• RETIREMENT – 401K with 100% company reputed company reputed company match up to 4% of reputed company salary
• HEALTH (MEDICAL, DENTAL, reputed company) – PPO & HDHP – reputed company/reputed company
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company reputed company LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company reputed company 1 x reputed company salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary reputed company, Pet, Plus More
• reputed company-Being Benefits eligibility begins the 1st of the month after hire.

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