Senior Computer System Validation Csv Jobs in California

Business Analyst – IT & Digital Transformation (Life Sciences)

Location: South San Francisco, CA (On-site

)Employment Type: Full-Time / Consultan

tIndustry: Pharmaceutical / Life Science

s
Join SII Group U

SASII Group USA is a leading engineering and technology consulting firm delivering innovative solutions to clients across Life Sciences, Healthcare, Manufacturing, Aerospace, Energy, and Digital Engineerin

g.We are currently seeking an experienced Business Analyst to support one of our strategic clients in the Pharmaceutical and Life Sciences industry based in South San Francisco, CA. This is an exciting opportunity to contribute to enterprise digital transformation initiatives within a highly regulated environment while collaborating with cross-functional teams to deliver impactful technology solution

s.
Position Overv

iew
The Business Analyst will operate in a fast-paced, evolving environment where collaboration, analytical thinking, and stakeholder engagement are essential to success. This role is responsible for evaluating business needs, defining functional requirements, and supporting the implementation of global technology solutions that align with strategic business objecti

ves.Working closely with business stakeholders, Project Managers, Solution Architects, Developers, and Quality teams, the successful candidate will ensure that business requirements are clearly documented, validated, tested, and successfully transitioned into production while maintaining compliance with Life Sciences quality and regulatory standa

rds.This position requires daily on-site presence in South San Franci

sco.
Key Responsibil

itiesBusiness Analysis & Requirements Gath

• eringPartner with business stakeholders, end users, and technical teams to elicit, analyze, document, and validate business and system requirem
• ents.Lead discovery sessions, stakeholder interviews, workshops, process mapping exercises, and use case develop
• ment.Translate business objectives into clear, actionable functional and technical requirem

ents.Cross-Functional Collabor

• ationWork closely with Project Managers, Architects, Developers, Engineers, UX Designers, and business leaders throughout the project lifec
• ycle.Support project planning activities by helping define project scope, objectives, business value, constraints, and success crit
• eria.Facilitate communication between technical and non-technical stakeholders to ensure shared understanding and align

ment.Documentation & Process Excel

• lenceProduce high-quality business and system documentation, inclu
• ding:User Requirements Specifications
• (URS)Functional and Technical Specifica
• tionsBusiness Process
• MapsWorkflow Dia
• gramsStandard Operating Procedures (
• SOPs)Process documentation and supporting mate
• rialsEnsure documentation complies with internal quality standards and regulatory expectat

ions.Testing, Validation & Compl

• ianceSupport User Acceptance Testing (UAT) planning, coordination, execution, and defect resolu
• tion.Develop Computer System Validation (CSV) documentation, including validation plans, test protocols, and traceability documenta
• tion.Ensure technology implementations comply with GxP requirements and established validation pract

ices.Requirements Lifecycle Manag

• ementMaintain end-to-end traceability of business requirements throughout the project lifec
• ycle.Evaluate requirement changes, assess business impact, and communicate updates to stakehol
• ders.Identify risks, issues, and dependencies that could impact successful project deli

very.Required Qualifica

• tionsBachelor's degree in Information Systems, Computer Science, Business, Engineering, or a related f
• ield.5–7 years of experience as an IT Business Analyst supporting enterprise technology initiat
• ives.Proven experience working across all phases of project delivery, including analysis, design, implementation, testing, and deploy
• ment.Strong understanding of Software Development Life Cycle (SDLC) methodologies, including Agile and Water
• fall.Experience with business process analysis, process improvement, and Organizational Change Management (
• OCM).Strong analytical, critical thinking, and problem-solving abili
• ties.Excellent documentation, facilitation, and stakeholder management sk
• ills.Outstanding written and verbal communication skills with the ability to simplify complex technical conc

epts.Preferred Qualifica

• tionsExperience within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences indu
• stry.Knowledge of GxP regulations, Computer System Validation (CSV), and regulated documentation pract
• ices.Experience writing validation documentation and test proto
• cols.Strong understanding of SQL, data flows, data mapping, and data integrity conc
• epts.Experience with Google Workspace (Docs, Sheets, Slides) and Microsoft Office S
• uite.Experience supporting Building, Campus Infrastructure, or Capital Construction technology projects is highly desir

able.What You'll

• BringA curious, proactive, and solution-oriented min
• dset.Exceptional attention to detail and organizational sk
• ills.Strong facilitation and stakeholder engagement capabili
• ties.Ability to thrive in fast-paced, evolving environments with changing priori
• ties.Excellent interpersonal skills with the ability to build relationships across business and technical organizat
• ions.A commitment to quality, compliance, and delivering measurable business v

alue.
Why Join SII Grou

p USA?At SII Group USA, you'll join a collaborative team of consultants working on innovative digital transformation programs for some of the world's leading Life Sciences organizations. We provide opportunities to develop your expertise, contribute to meaningful projects, and build a rewarding career in consulting and techn

ology.If you're passionate about business analysis, digital transformation, and solving complex challenges in a highly regulated environment, we'd love to hear fro

m you.SII Group USA is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive workplace where all employees are treated with respect and provided equal opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, or any other characteristic protected by applicabl