Csv Validation Jobs in San Ramon, CA (NOW HIRING)

This is a hybrid role requiring two days per week in our Concord, CA office.

Position Summary

Cerus is seeking a hands-on IT Portfolio & Project Manager to bring structure, visibility, and execution rigor to how IT work is requested, evaluated, prioritized, approved, tracked, and communicated. This role will serve as the initial "PMO-of-one," building foundational project intake and governance practices while directly managing and delivering IT projects end-to-end. The successful candidate will reduce reliance on technical SMEs as ad-hoc project managers, improve strategic alignment and decision-making, and increase delivery predictability - while ensuring IT projects and computerized systems meet applicable regulatory and validation requirements.

Key Responsibilities

Portfolio Intake, Triage, and Prioritization

• Establish and manage a single front door for IT demand (intake forms, triage workflow, and centralized backlog).
• Develop and maintain simple definitions and thresholds to classify work (request vs enhancement vs project) and apply the appropriate level of governance.
• Partner with IT leadership and business stakeholders to implement a lightweight prioritization approach (scoring for strategic alignment, urgency, risk, effort).
• Facilitate regular portfolio review meetings to drive clear outcomes: approve, defer, reject, or request discovery and with decisions captured and communicated.

Stakeholder, Cross-Functional, and Vendor Collaboration

• Serve as the primary point of contact between IT, business stakeholders, and vendors for assigned projects and portfolio initiatives.
• Translate business needs into actionable requirements, project charters, and delivery plans in partnership with IT SMEs and functional owners.
• Facilitate project status meetings and communicate progress, risks, dependencies, and decisions to stakeholders and leadership.
• Proactively manage expectations, align on scope and outcomes, and drive timely decisions and issue resolution.

Project Delivery (Hands-On Execution)

• Directly manage and deliver IT projects (systems implementations, infrastructure initiatives, cybersecurity/compliance projects, process improvements) from intake through closeout.
• Lead project planning activities: scope definition, milestones, stakeholder alignment, communications, and implementation planning.
• Drive execution discipline: weekly status, issue/risk management, dependency tracking, change control, and escalation.
• Coordinate cross-functional delivery teams so SMEs can focus on technical execution while you manage planning, coordination, and stakeholder alignment.

Computer System Validation (CSV) and Regulatory Compliance

• Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in alignment with company procedures.
• Ensure IT systems and project deliverables comply with applicable regulations and standards (FDA 21 CFR Part 11, ISO 13485, and GxP where applicable).
• Incorporate CSV, SDLC controls, and regulatory requirements into project plans, timelines, and deliverables (requirements, risk assessments, traceability, testing, approvals, and evidence packages).
• Collaborate with stakeholders and system owners to address data integrity, cybersecurity considerations, and validation expectations for computerized systems.

Governance, Reporting, and Communication

• Build and run an IT project governance cadence (weekly/biweekly) that provides visibility into status, risks, dependencies, and decisions needed.
• Maintain an auditable decision log and ensure stakeholders understand tradeoffs, scope impacts, and sequencing.
• Produce executive-ready portfolio dashboards and summaries.
• Standardize project documentation and templates

Financial and Vendor Management

• Implement a practical approach to project financial tracking starting with vendor/SOW costs (quotes, POs, invoices) plus rough internal effort estimates to support forecasting and tradeoffs.
• Track forecast vs actual costs for project work and highlight variances, risks, and decision points.
• Coordinate vendor milestones/deliverables and ensure invoicing aligns to outcomes.

Continuous Improvement and Enablement

• Identify bottlenecks, propose improvements, and evolve governance based on feedback and adoption.
• Coach and enable IT staff on consistent project practices (templates, reporting rhythm, role clarity).
• Contribute to an IT roadmap view by linking demand and projects to business priorities and compliance/security needs.

Required Qualifications

• Bachelor's degree in Information Systems, Business, Project Management, or equivalent experience.
• 5+ years of IT project management experience in a regulated environment (medical devices, pharma, biotech, healthcare).
• Strong understanding of CSV, SDLC, and regulatory requirements for computerized systems.
• Familiarity with data integrity, cybersecurity, and FDA 21 CFR Part 11 compliance concepts.
• Demonstrated experience establishing or improving project processes (intake, governance, reporting) in an environment with limited prior structure.
• Strong ability to communicate project status and issues clearly to both technical and non-technical audiences.

Preferred Qualifications

• Hands-on experience supporting or leading Computer System Validation (CSV) for enterprise applications and/or infrastructure supporting regulated processes.
• Familiarity with FDA, ISO (including ISO 13485), and GxP regulations/expectations.
• Experience coordinating vendor-led projects and managing SOW-based delivery.
• Project management certification (PMP, CAPM, PMI-ACP, Scrum Master) is a plus but not required.

Core Competencies

• Builder + Doer mindset: creates structure while actively delivering projects.
• Execution rigor: anticipates risks, manages dependencies, and drives closure.
• Facilitation and influence: aligns stakeholders, resolves conflict, and drives decisions.
• Clear communication: concise, consistent, transparent reporting; strong written documentation.
• Compliance-minded delivery: embeds CSV/SDLC controls and evidence expectations into plans and execution.

We understand that our people are essential to our success.  This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.

Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs

Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement

Compensation: The base salary range for this position in the selected city is $144,000-$174,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.