Senior Manager, MS&T – Product Process Validation (PPV)

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. 

The Impact You Will Make

The 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 Responsibilities 

Product & 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  

• Fill-Finish Operations  

• Visual Inspection Trending  

• Process Validation & Cleaning Validation  

• Deviation Investigations & CAPA  

• Lean Manufacturing / Continuous Improvement  

• Risk Assessments & FMEA  

• GMP Compliance & Inspection Readiness  

• Change Management  

• 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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