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Open nowPosted 18 hours ago

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

kindeva79 open roles

Where
Maryland Heights, MO, USA
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Your applicationOpen nowSenior Manager, MS&T – Product Process Validation (PPV)kindeva · Maryland Heights, MO, USA

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This job: posted 18 hours ago

The posting

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  

  #LI-Onsite

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