The Impact You Will MakeThe Senior Manager, MS&T - PPV, CPV & Operational Excellence will lead Product Process Validation (PPV), Continued Process Verification (CPV), process monitoring, statistical trending, and continuous improvement initiatives across sterile injectable and biologics manufacturing operations within a fast-paced CDMO environment.
This role is responsible for validation lifecycle management, aseptic process support, process performance monitoring, operational excellence initiatives, and sustained state of control for commercial and late-stage clinical manufacturing processes. The position partners cross-functionally with Manufacturing, Quality, Validation, Regulatory, Engineering, and Supply Chain to ensure compliant, efficient, and inspection-ready operations supporting sterile injectable products, biologics, and complex fill-finish platforms.
The ideal candidate has deep experience supporting aseptic manufacturing and fill-finish operations, combined with strong technical expertise in process performance trending, data analytics, deviation investigations, CAPA effectiveness, and continuous improvement methodologies. Experience in biologics and external manufacturing/CDMO environments is strongly preferred.
Key ResponsibilitiesProduct & Process Validation - Lead Product Process Validation (PPV) activities for sterile injectable and biologic manufacturing processes including aseptic fill-finish operations, visual inspection, assembly, and packaging systems.
- Provide technical leadership for validation lifecycle activities including process design, qualification strategy, PPQ protocol development/execution, and continued process verification.
- Partner with Validation, Manufacturing, Engineering, and Quality teams to ensure validation activities are scientifically sound, compliant, and aligned with regulatory expectations.
- Develop and review validation documentation including:
- Validation Master Plans (VMPs)
- PPQ protocols and reports
- Risk assessments
- Sampling plans
- Statistical analysis plans
- Continued verification reports
- Analyze PPQ and commercial manufacturing data to evaluate process capability, variability, and sustained state of control.
- Ensure validation strategies appropriately incorporate:
- Critical Process Parameters (CPPs)
- Critical Quality Attributes (CQAs)
- Process performance trending
- Statistical justification and acceptance criteria
- Support technology transfer and new product introductions through validation readiness assessments and process performance monitoring.
- Lead validation-related investigations, deviation assessments, and implementation of corrective and preventive actions (CAPA).
- Support regulatory inspections and client audits by presenting validation strategies, lifecycle data, and process performance trending analyses.
- Drive continuous improvement initiatives resulting from validation findings, CPV monitoring, and manufacturing trend analysis.
- Ensure alignment with FDA Process Validation guidance, Annex 1 expectations, and global GMP requirements for sterile manufacturing environments.
- Continued Process Verification (CPV) Leadership
- Lead site and product-level Continued Process Verification (CPV) programs for sterile injectable and biologic manufacturing processes.
- Develop and maintain CPV strategies, monitoring plans, statistical methodologies, and process performance metrics aligned with FDA Process Validation Stage 3 requirements.
- Establish and monitor critical process parameters (CPPs), critical quality attributes (CQAs), and key performance indicators (KPIs) to ensure continued process control.
- Analyze and trend manufacturing, environmental monitoring, visual inspection, yield, deviation, and quality data to proactively identify process shifts, variability, and emerging risks.
- Drive implementation of statistical trending tools, control charts, and data visualization systems to support proactive process monitoring and decision-making.
- Author CPV reports, annual product reviews, trend reports, and technical assessments supporting regulatory submissions and inspections.
- Continuous Improvement & Operational Excellence
- Lead continuous improvement initiatives focused on process capability, throughput, cycle time reduction, yield improvement, deviation reduction, and Right First Time (RFT) performance.
- Utilize Lean Manufacturing, Six Sigma, and risk-based methodologies to improve manufacturing performance and operational reliability.
- Drive root cause investigations and sustainable CAPA implementation using structured problem-solving tools.
- Partner with Manufacturing and Engineering to optimize aseptic processes, visual inspection operations, assembly, and packaging performance.
- Identify opportunities for automation, digitization, and enhanced data analytics to improve operational visibility and process control.
- Support operational readiness for new product introductions, process transfers, and scale-up activities.
- Utilize statistical tools and manufacturing data systems to identify adverse trends and drive data-based decision making.
- Partner with Digital, Automation, and IT teams to improve manufacturing data accessibility and reporting capabilities.
Technical & Cross-Functional Leadership - Serve as MS&T Validation SME supporting aseptic fill-finish manufacturing including vial, cartridge and prefilled syringe operations.
- Collaborate with Quality, Regulatory Affairs, Validation, QC, and Manufacturing to maintain compliance and support inspection readiness.
- Support Health Authority inspections and customer audits through preparation of technical justifications, trend analyses, and CPV documentation.
- Lead technical governance meetings reviewing process performance, quality trends, and continuous improvement opportunities.
- Provide technical assessment and risk evaluation support for change controls, deviations, investigations, and process modifications.
Leadership & Team Development - Mentor engineers and technical staff in PPV, CPV methodologies, statistical analysis, and continuous improvement practices.
- Develop SOPs, training curricula, and technical standards supporting lifecycle process management.
- Foster a culture of operational excellence, accountability, and proactive quality management.
- Support organizational capability building across MS&T and manufacturing operations.
Qualifications Education - Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, or related technical discipline required.
- Advanced degree preferred (MS, MBA, MSEM, or equivalent).
Experience - 10+ years of experience in pharmaceutical, biologics, or sterile injectable manufacturing environments.
- Strong experience in MS&T, Technical Operations, Process Engineering, or Manufacturing Support roles.
- Demonstrated expertise in Continued Process Verification (CPV), statistical process monitoring, and process lifecycle management.
- Experience supporting sterile injectable aseptic processing and fill-finish operations.
- Experience leading deviation investigations, CAPA, change management, and continuous improvement programs.
- Strong understanding of FDA Process Validation guidance, GMP compliance, and regulatory expectations.
- Experience within a CDMO and/or external manufacturing environment preferred.
- Experience with biologics, vaccines, CGT, or complex injectable products strongly preferred.
Technical Competencies - Continued Process Verification (CPV)
- Statistical Process Control (SPC)
- Process Trending & Data Analytics
- Aseptic Processing & Sterile Manufacturing
- Visual Inspection Trending
- Process Validation & Cleaning Validation
- Deviation Investigations & CAPA
- Lean Manufacturing / Continuous Improvement
- GMP Compliance & Inspection Readiness
- Manufacturing Data Systems & KPI Development
- Technical Writing & Regulatory Documentation
Preferred Systems & Tools - JMP, Minitab, Spotfire, Power BI, or similar statistical/trending platforms
- MES, DeltaV, PI Historian, SAP, TrackWise, VEEVA or equivalent systems
- Knowledge of automation and digital manufacturing systems
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