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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