Veridius Biopharm Consulting
When you partner with Veridius you know you are bringing a Senior Technical Leader into your GMP operation
Veridius provides hands-on MSAT/Technical Services, Validation, and Analytics support that helps sites stabilize processes, complete validation work, reduce investigation burden, and improve audit readiness. Built for biotech teams and staffing partners who need a strong contributor who can start fast and deliver.
Validation ExecutionMSAT and Floor SupportCPV, PAT, AnalyticsInvestigation and CAPA
What Clients and Staffing Partners Utilize Veridius Consultants For:
- Process validation and PPQ support, protocol authoring, execution help, and closure packages
- Cleaning and utilities work (CIP/WFI), reliability improvements, and documentation support
- Equipment and utility qualification support, plus validation-minded troubleshooting
- Computer systems and monitoring support with a data integrity mindset
- Investigation triage, root cause, CAPA effectiveness, and backlog reduction
- CPV/PAT and multivariate analytics that drive decisions, not dashboards
Engagement types: W2 contract, C2C, and project-based support. Onsite in RTP area, travel available.
Lifecycle monitoring loop (Tech Transfer to CPV/PAT)
Capabilities
Biopharma execution wins when documentation and data are aligned with how the process actually runs. Veridius combines validation rigor, MSAT practicality, and analytics that remain inspection-ready and sustainable for the site after handoff.
Validation that moves the floor
Plans, protocols, and execution support that reduce cycle time while keeping justification strong and traceable.
MSAT support that stabilizes operations
Troubleshoot, assess risk, tighten control strategy, and drive reliable performance across upstream, downstream, and utilities.
Analytics that drives decisions
CPV, PAT, and multivariate monitoring that separates noise from real risk and turns signals into action.
Digital monitoring with a data integrity mindset
Automation and monitoring that improves visibility without introducing compliance risk or unsustainable complexity.
Services
Clear offerings built for speed and accountability. Each engagement starts with defined outcomes, a practical plan, and inspection-ready documentation.
Validation and Qualification Execution
Hands-on validation leadership that reduces cycle time, strengthens justification, and holds up to audit. Built for process, cleaning, equipment and utility qualification, and computer systems support.
- Validation strategy, VMP-aligned plans, and risk-based protocols
- Protocol authoring and execution support (IQ/OQ/PQ, PPQ), with clear deviations and closure packages
- Data analysis, summary reporting, and inspection-ready traceability across requirements, risk, and testing
Investigations, Deviations, and CAPA Programs
Backlog reduction and investigation quality improvements. Fast triage, clear ownership, and effective CAPA that prevents recurrence.
- Deviation triage, root cause, and CAPA effectiveness
- Backlog burn-down programs with governance, metrics, and cadence
- Cross-functional alignment across Manufacturing, QA, MSAT, QC, and Engineering
Embedded MSAT and Technical Services Support
Senior floor-facing technical leadership across upstream, downstream, and supporting utilities. Troubleshoot, stabilize, and improve.
- Shop-floor support, technical risk assessment, and decision support
- Batch support, change impact assessment, and technical documentation
- Utilities and cleaning optimization (CIP/WFI), robustness, and reliability improvements
Tech Transfer, PPQ, and Lifecycle Strategy
Execution support for NPI, technology transfer, process characterization, and PPQ. Practical QbD and control strategy that scales.
- Process characterization and PPQ planning and execution support
- Control strategy and CPP/CQA linkage with sound justification
- Lifecycle validation and continued verification plans tied to real operations
CPV, PAT, and Multivariate Analytics
Inspection-ready analytics that reduce noise and drive action. Designed to be sustainable for the site after handoff.
- CPV design, governance, and trending that drives decisions
- Multivariate analytics (PCA/PLS) for CPP/CQA insights and early warning
- SIMCA Online SME support, model sustainment, and practical PAT strategy
Automation and Digital Monitoring
Data systems and monitoring that improve reliability without creating compliance risk. Built for real-time visibility and data integrity.
- DeltaV support, automation strategy, and practical historian-aligned reporting
- Near real-time monitoring concepts and escalation workflows
- Documentation support aligned to cGMP expectations for data and decision use
Engagements
Designed to work cleanly for both biotech sites and contract staffing partners. You get a senior technical contributor who can lead or execute, with clear deliverables and a straightforward operating cadence.
For Biotech Manufacturing Sites
Ideal when you need an embedded technical leader to stabilize operations, complete validation work, and improve inspection readiness.
- Validation execution support (process, cleaning strategy, equipment and utilities, CSV support)
- MSAT troubleshooting, change impact assessment, and decision support
- Investigation triage, root cause, CAPA effectiveness, and backlog reduction
- CPV/PAT and multivariate monitoring tied to actionable decisions
For Contract Staffing Partners
Easy to represent and easy to place. Strong outcomes, clear scope fit, and experience partnering across QA, MSAT, QC, Engineering, and leadership.
- Contract types: W2, C2C, and project-based
- Roles: Validation Lead, MSAT Lead, CPV/PAT SME, Investigation Program Lead, Technical Services Lead
- Onsite RTP area. Travel available by engagement needs
- Communication style: clear updates, measurable progress, and practical documentation
Typical Deliverables
Deliverables are designed to fit the client quality system and maintain traceability. Limits and decisions are justified through data and risk.
- Plans, protocols, execution notes, and summary reports (IQ/OQ/PQ, PPQ, CPV)
- Risk assessments and justification packages that support change control and readiness
- Investigation packages with strong root cause and CAPA effectiveness
- Monitoring and trending packages that translate signals into actionable decisions
Proof
Veridius is built around execution and measurable outcomes. These are representative results from major site initiatives and programs.
340+
Investigations closed
In under 6 months while maintaining inspection readiness
43
STS team built and led
Scaled from 4 to 43 engineers and scientists
3%+
Annual production cost reduction
Delivered through yield, scrap, and cycle-time improvements
11%
Yield increase
Upstream variability reduction through process and raw material controls
445k
Gallons WFI waste eliminated per year
Cleaning strategy optimization and automation improvements
20+
Audits supported
Regulatory and client audits with strong technical readiness
20+
Regulatory Documents
Authored for FDA, EMA, and Health Canada submissions
18
Clinical batches executed
Right-first-time execution with yields above targets
Investigation Backlog Reduction Program
340+ investigations closed in under 6 months
Implemented structured triage, clarified ownership, and raised investigation quality so the site reduced backlog quickly while maintaining inspection readiness.
Upstream Variability Reduction
11% yield increase through practical control improvements
Reduced fermentation media variability and improved yield using upstream process and raw material controls with monitoring strategies that sustained performance.
Cleaning, CIP/WFI, and Utility Optimization
445,000 gallons per year WFI waste eliminated and improved CIP reliability
Improved cleaning strategy and automation execution to reduce waste, improve reliability, and support consistent operation under GMP expectations.
CPV and Digital Monitoring Enablement
Standardized CPV/PAT approaches and enabled data-driven decision support
Built multivariate monitoring and CPV governance with platforms such as SIMCA Online and DeltaV so that quality signals drove proactive action.
Automated Statistical Monitoring Foundation
VBA/SQL/HTML monitoring program enabling early shift detection
Designed and implemented automated statistical process monitoring concepts to detect process shifts early and align reporting with cGMP and data integrity expectations.
Expertise
Deep GMP manufacturing experience across biologics and vaccines, with hands-on technical leadership in validation, investigations, CPV, PAT, automation, and audit readiness.
Approach
Veridius works like an embedded senior technical leader. We prioritize what unblocks the floor, quantify success, and leave behind durable systems that scale and stand up to inspection.
Diagnose quickly
Structured assessment to identify the true constraint, the compliance risk, and the minimum path to impact.
Align and govern
Clear ownership, decision cadence, and success criteria so teams move together and rework drops.
Execute and simplify
Hands-on support that reduces cycle time and complexity while keeping documentation inspection-ready.
Sustain and transfer
Practical training, playbooks, and monitoring that prevents backslide and improves long-term reliability.
Contact
Reach out to discuss scope, timing, and the fastest path to measurable GMP impact. I work with biotech sites directly and with staffing partners.
Research Triangle Park (RTP), North Carolina ·