Summary:

The Veeva Configuration Specialist IT role serves as a techno-functional expert for Vaxcyte’s current and future Veeva applications and related technologies. Working closely with business and managed services partners, this role is responsible for implementing, managing, and maintaining Quality, Regulatory and Clinical Veeva Vault system configurations and other GxP and Non GxP enterprise applications. While technical in nature, this role drives business value by blending technology expertise with business process know-how. This is a hands-on role that reports to the Associate Director of Enterprise IT Systems at Vaxcyte’s San Carlos, California headquarters.

Essential Functions:

• Lead requirements gathering, impact assessments, analysis, design, and configuration activities.
• Customize and configure Veeva Vault applications to meet business requirements.
• Provide Veeva admin and operational support for issues impacting end-users, system unavailability, data integrity, and manage user account provisioning.
• Help develop and document business process flows.
• Create and maintain system-specific IT documentation such as configuration forms, business processes, operating procedures, templates and design standards.
• Establish and maintain close working relationships with cross functional business partners.
• Collaborate with stakeholders to understand current business processes and identify areas for improvement and optimization.
• Work with other IT teams to ensure seamless integration with other systems.
• Provide project management support for enhancement efforts.
• Follow GxP change management processes for system configuration changes and platform upgrades.
• Support periodic reviews and related compliance activities.
• Coordinate with managed services, business partners and assurance teams to implement planned releases and functional change requests.

Requirements: 

• Bachelor’s degree in computer science, information systems, or related field. Minimum 3 years of hands-on configuration experience with any Veeva Vault Platform systems and minimum 7 years of total IT Systems experience. Other combinations of education and/or experience may be considered.
• Strong understanding of Veeva application suites including Quality (QualityDocs, QMS, Vault Training), RIM and Clinical eTMF.
• Experience with validated GxP environments including implementation, documentation and change management is a must.
• Extensive experience as a business systems analyst for Enterprise IT systems.
• Veeva system administration certification is a plus.
• As is/to be process mapping and analysis.
• Solid problem-solving skills and ability to troubleshoot issues including root cause analysis.
• Excellent verbal and written communication skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
• Technical writing skills for updating SOPs, WIs, Knowledgebase articles and documenting business processes.

Summary:

The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational requirements throughout the system lifecycle. The role focuses on traditional Computer System Validation with application of risk-based Computer Software Assurance (CSA) principles where appropriate.

The individual will work closely with IT and Quality teams to validate and maintain GxP systems across their lifecycle. Strong experience validating relational databases, cloud infrastructure, and integrated applications in regulated biotech or pharmaceutical environments is required.

This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.

This is a hybrid role with minimum of 3 days a week onsite at San Carlos, CA location.

Essential Functions:

• Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
• Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.
• Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles.
• Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements
• Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.
• Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation.
• Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated.
• Support change control, deviation management, periodic review, and lifecycle management of validated systems.
• Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
• Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.

Requirements: 

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
• Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
• Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
• Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
• Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
• Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
• Strong technical writing skills and ability to create comprehensive validation documentation.
• Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders.

Other combinations of education and/or experience may be considered.

Preferred Qualifications:

• Hands-on experience validating cloud based GxP systems, specifically Azure.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
• Experience applying CSA principles to custom data applications in GxP cloud.
• Microsoft Azure or similar technical certifications.

Summary:

We are seeking a highly experienced Senior Software Engineer with deep full-stack expertise and a strong DevOps orientation. This individual will play a key role in designing, building, testing, and operating scalable web applications that support critical business functions.

The ideal candidate combines strong frontend and backend development capabilities with a disciplined approach to automation, testing, CI/CD, and production reliability. This role requires technical leadership, architectural judgment, and the ability to drive engineering excellence across the software lifecycle.

Essential Functions:

Full-Stack Application Development

• Architect, design, and implement scalable applications using Next.js and React
• Develop and maintain backend services and GraphQL APIs, including schema design and performance optimization
• Ensure high standards for code quality, security, performance, and maintainability
• Participate in architectural design reviews and technical decision-making

Testing & Quality Engineering

• Lead implementation of comprehensive automated testing strategies, including:
• End-to-end UI testing (e.g., Playwright, Cypress)
• API and integration testing
• Unit and regression testing
• Establish and enforce best practices for test coverage and quality gates
• Improve system stability through proactive quality engineering practices

DevOps & Continuous Delivery

• Design, implement, and optimize CI/CD pipelines using GitHub Actions
• Automate build, test, and deployment workflows across environments
• Improve release reliability, deployment frequency, and rollback strategies
• Contribute to monitoring, logging, and observability improvements
• Support production systems and participate in incident resolution when needed

Technical Leadership

• Mentor engineers and provide guidance on architecture and best practices
• Contribute to engineering standards and documentation
• Drive continuous improvement in development processes and tooling
• Collaborate cross-functionally with Product, Design, and Infrastructure teams

Requirements: 

• Bachelor’s degree in Computer Science, Engineering, or related field (or equivalent experience)
• Minimum 5 years of professional software engineering experience and a minimum of 4 years of experience in modern frontend frameworks, including Next.js and React. Other combinations of education and/or experience may be considered.
• Strong experience designing and implementing GraphQL APIs
• Proven experience in full-stack system architecture and development
• Demonstrated experience implementing automated testing for UI and APIs
• Hands-on experience building and maintaining GitHub Actions CI/CD workflows
• Strong understanding of DevOps principles, continuous delivery, and production system reliability
• Experience working with scalable, production-grade applications
• Excellent communication skills and ability to lead technical initiatives

Preferred Qualifications

• Experience deploying and managing applications in Microsoft Azure
• Experience with Terraform or other Infrastructure-as-Code solutions
• Familiarity with containerization (Docker) and modern deployment patterns
• Experience with monitoring and observability platforms
• Familiarity with AI-assisted development tools such as ChatGPT, Claude, or similar platforms
• Experience integrating AI APIs or intelligent automation into applications
• Strong architectural and systems design capability
• Ownership mindset with accountability for outcomes
• Commitment to automation and operational excellence
• Ability to balance technical rigor with delivery timelines
• Continuous learner who leverages modern tools, including AI-assisted development
• Other combinations of education and/or experience may be considered.

Summary:

Vaxcyte is undergoing a major ERP transformation, moving to SAP S/4HANA to support its rapid growth and upcoming transition to Commercial Operations. The IT SAP Supply Chain Senior Business Systems Analyst (BSA) will play a critical role in bridging Supply Chain and IT, ensuring successful implementation, stabilization, and ongoing optimization of SAP S/4HANA Supply Chain capabilities. This position requires strong functional expertise in SAP Supply Chain functionalities, deep understanding of contract manufacturing processes, and experience in complex ERP implementation projects.

Essential Functions:

• Support the implementation and stabilization of SAP S/4HANA Supply Chain modules in a regulated environment.
• Collaborate with Supply Chain, Manufacturing, Quality, and IT teams to design future-state processes aligned with Vaxcyte's CDMO business model.
• Assist in data mapping, migration, cleansing, and validation during cutover and post-go-live activities.
• In-depth knowledge of SAP S/4HANA systems and integration techniques with third-party planning systems.
• Expertise with agile methodology, global deployments, and data migration planning.
• Experience working in GxP validated and SOX regulated systems.
• Configure and maintain SAP Supply Chain modules including Materials Management (MM), Master Data, Subcontracting & External Processing, Batch Management, and Forecast Consumption & Demand Planning.
• Assist with the integration points with FI (Financial Accounting) & CO (Controlling)
• Support end-to-end planning flows from demand through manufacturing and supply execution.
• Excellent verbal and written communication skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
• Work closely with Supply Chain stakeholders (Planning, Procurement, Finance) to capture requirements.
• Translate business needs into functional specifications for SAP configuration.
• Help develop and document business process flows.
• Support complex planning scenarios where capacity, lead times, and execution are controlled by external CDMO partners.
• Develop and execute test plans for SAP Supply Planning processes.
• Support User Acceptance Testing (UAT) and resolve issues promptly.
• Ensure validation readiness and maintain audit trail expectations in compliance with regulatory requirements.
• Training & Change Management
• Create training materials and deliver sessions for Supply Chain users.
• Provide ongoing support post go-live.
• Ensure compliance with GxP standards and Life Sciences industry requirements.

Requirements: 

• Minimum of 7 years of experience as a BSA with SAP Supply Chain modules.
• Bachelor's degree in Supply Chain, Operations, Information Systems, or related field
• Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve SAP supply chain issues in complex CDMO-based manufacturing environments.
• Experience in identifying and managing project risks, with a proactive approach to mitigation.
• Familiarity with change management principles and techniques to facilitate smooth transitions and adoption of new systems.
• Hands-on experience with SAP S/4HANA Supply Chain (implementation or migration projects preferred) and Fiori applications.
• Proven experience supporting SAP-based contract manufacturing or CDMO operating models.
• Experience developing and mapping business process flows using Visio or similar tool.
• Strong understanding of Supply Chain processes and ERP implementation best practices.
• Excellent communication and stakeholder management skills.
• Solid experience managing SAP master data relevant to supply planning (materials, vendors, sourcing, BOMs).

• Other combinations of education and/or experience may be considered.

Summary:

Vaxcyte’s IT team is seeking a motivated, forward-thinking Manager, IT Quality & Compliance to support executing and supporting IT Quality, Compliance, and Validation (CSV/CSA) activities across GxP systems. This role partners closely with the Director of IT Quality & Compliance to operationalize the IT QSC (Quality, Security, Compliance) strategy and ensure systems remain compliant, secure, and audit-ready. This is a hands-on role requiring expertise in IT system validation, auditing, vendor management, and compliance operations within a regulated GxP environment.

Essential Functions:

IT Validation & CSV/CSA Execution

• Execute Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for GxP systems.
• Support validation lifecycle activities (planning, testing, documentation, release, and change management).
• Provide ITQA oversight for implementation of GxP systems.
• Support data migration validation (reconciliation, traceability, and verification).

Audit & Inspection Readiness

• Perform internal IT CSV audits to ensure regulatory and procedural compliance.
• Support and execute GxP vendor audits.
• Prepare audit documentation, evidence packages, and formal audit reports.
• Support regulatory inspections and inspection readiness activities.

Vendor Management & Oversight

• Conduct vendor qualification and periodic vendor audits.
• Support vendor risk assessments and compliance monitoring.
• Ensure vendors meet GxP, data integrity, and security requirements.

Periodic Reviews & Compliance Monitoring

• Perform periodic reviews of GxP systems to maintain validated state.
• Identify compliance gaps and drive remediation.
• Support continuous audit and compliance monitoring programs.

Investigations & CAPA Management

• Support IT investigations (deviations, incidents, compliance gaps).
• Author and manage CAPAs, ensuring timely closure and effectiveness.
• Partner cross-functionally to implement corrective and preventive actions.

Documentation & SOP Development

• Author and maintain IT and QA SOPs, policies, and work instructions.
• Ensure alignment with GxP and 21 CFR Part 11 requirements.
• Support continuous improvement of documentation and processes.

Data Integrity, Cybersecurity & Infrastructure Alignment

• Support implementation of data integrity controls (ALCOA+).
• Partner with IT Security to align compliance with cybersecurity controls (access, logging, monitoring).
• Ensure infrastructure supporting GxP systems is maintained in a secure and compliant state (patching, backup, recovery).
• Identify and escalate risks related to data integrity, cybersecurity, and infrastructure.

Training & Cross-Functional Collaboration

• Support IT Quality & Compliance training initiatives.
• Collaborate across IT, Security, Quality, and business teams.
• Promote a culture of compliance, quality, and audit readiness.

Requirements:

• Bachelor’s degree in IT, Quality, Life Sciences, or related field and minimum 5 years of experience in IT Quality, CSV/CSA, or compliance in a GxP environment. Other combinations of education and/or experience may be considered.
• Hands-on experience with:
  • IT system validation (CSV/CSA)
  • Internal and vendor audits
  • Periodic reviews of GxP systems
  • Vendor management and oversight
  • Data migration validation
• Experience supporting or working with laboratory (GxP lab) and manufacturing systems (e.g., MES, LIMS, lab instruments)
• Experience with Veeva, ERP systems, or regulated SaaS platforms
• Experience supporting or implementing GxP systems from a QA perspective
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles
• Experience authoring SOPs, validation documentation, CAPAs, and investigations

Preferred:

• Experience in life sciences or biotech environments.
• Experience writing and presenting audit reports and familiarity with risk management frameworks.
• Exposure to QSC (Quality, Security, Compliance) integration and knowledge of data governance and data integrity practices.
• Working knowledge of cybersecurity (access control, data protection, incident response).
• Exposure to IT security and infrastructure controls (patching, system hardening).
• Experience using AI tools for research, analysis, and process optimization.

Summary:

Vaxcyte is undergoing a major ERP transformation, moving from NetSuite to SAP S/4HANA to support its rapid growth and upcoming transition to commercial operations. The Senior IT Business Systems Analyst (BSA), SAP Finance will play a critical role in bridging Finance and IT, ensuring a smooth transition and successful implementation of SAP S/4HANA Finance modules. This position requires strong functional expertise in SAP Finance, deep understanding of accounting processes, and experience in ERP migration projects. 

Essential Functions:

• Support the migration from NetSuite to SAP S/4HANA, ensuring data integrity and process continuity. 

• Collaborate with Finance and IT teams to design future-state processes aligned with Vaxcyte’s business needs.  

• Assist in data mapping, cleansing, and validation during migration. 

• In-depth knowledge of SAP systems, including SAP S/4HANA and integration techniques. 

• Configure and maintain SAP Finance modules including Financial Accounting (FI), Controlling (CO), Treasury & Cash Management, Financial Close & Reporting, and Procurement.  

• Work closely with Finance stakeholders (Accounting, FP&A, Procurement) to capture requirements. 

• Translate business needs into functional specifications for SAP configuration. 

• Help develop and document business process flows. 

• Develop and execute test plans for SAP Finance processes. 

• Support User Acceptance Testing (UAT) and resolve issues promptly. 

• Create training materials and deliver sessions for Finance users transitioning from NetSuite. 

• Provide ongoing support post go-live. 

• Ensure compliance with GAAP and biotech industry standards. 

Requirements: 

• Minimum 7 years of experience as a BSA with SAP Finance modules. Other combinations of education and/or experience may be considered. 

• Bachelor’s degree in Finance, Accounting, Information Systems, or related field. 

• Strong analytical and problem-solving skills, with the ability to identify issues and implement effective solutions. 

• Experience in identifying and managing project risks, with a proactive approach to mitigation. 

•  Familiarity with change management principles and techniques to facilitate smooth transitions and adoption of new systems. 

• Hands-on experience with SAP S/4HANA Finance (implementation or migration projects preferred) and Fiori applications.  

• Experience with Netsuite preferred. 

• Experience developing and mapping business process flows using Visio or similar tool 

• Strong understanding of financial processes and ERP migration best practices. 

• Excellent communication and stakeholder management skills. 

• SAP certification in FI/CO 

• Expertise with agile methodology, global deployments, and data migration planning. 

• Experience working in GxP validated and SOX regulated systems 

• Knowledge of integrated tools (e.g., BlackLine, Concur, Ariba) and reporting solutions. 

• Other combinations of education and/or experience may be considered.