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

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around 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 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 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 ResponsibilitiesProduct & Process ValidationLead Product Process Validation (PPV) activities for sterile injectable and biologic manufacturing processes including aseptic fill-finish operations visual inspection assembly and packaging technical leadership for validation lifecycle activities including process design qualification strategy PPQ protocol development/execution and continued process with Validation Manufacturing Engineering and Quality teams to ensure validation activities are scientifically sound compliant and aligned with regulatory and review validation documentation including:Validation Master Plans (VMPs)PPQ protocols and reportsRisk assessmentsSampling plansStatistical analysis plansContinued verification reportsAnalyze PPQ and commercial manufacturing data to evaluate process capability variability and sustained state of validation strategies appropriately incorporate:Critical Process Parameters (CPPs)Critical Quality Attributes (CQAs)Process performance trendingStatistical justification and acceptance criteriaSupport technology transfer and new product introductions through validation readiness assessments and process performance 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 continuous improvement initiatives resulting from validation findings CPV monitoring and manufacturing trend alignment with FDA Process Validation guidance Annex 1 expectations and global GMP requirements for sterile manufacturing Process Verification (CPV) LeadershipLead site and product-level Continued Process Verification (CPV) programs for sterile injectable and biologic manufacturing and maintain CPV strategies monitoring plans statistical methodologies and process performance metrics aligned with FDA Process Validation Stage 3 and monitor critical process parameters (CPPs) critical quality attributes (CQAs) and key performance indicators (KPIs) to ensure continued process and trend manufacturing environmental monitoring visual inspection yield deviation and quality data to proactively identify process shifts variability and emerging implementation of statistical trending tools control charts and data visualization systems to support proactive process monitoring and CPV reports annual product reviews trend reports and technical assessments supporting regulatory submissions and Improvement & Operational ExcellenceLead continuous improvement initiatives focused on process capability throughput cycle time reduction yield improvement deviation reduction and Right First Time (RFT) Lean Manufacturing Six Sigma and risk-based methodologies to improve manufacturing performance and operational root cause investigations and sustainable CAPA implementation using structured problem-solving with Manufacturing and Engineering to optimize aseptic processes visual inspection operations assembly and packaging opportunities for automation digitization and enhanced data analytics to improve operational visibility and process operational readiness for new product introductions process transfers and scale-up statistical tools and manufacturing data systems to identify adverse trends and drive data-based decision with Digital Automation and IT teams to improve manufacturing data accessibility and reporting & Cross-Functional LeadershipServe as MS&T Validation SME supporting aseptic fill-finish manufacturing including vial cartridge and prefilled syringe with Quality Regulatory Affairs Validation QC and Manufacturing to maintain compliance and support inspection Health Authority inspections and customer audits through preparation of technical justifications trend analyses and CPV technical governance meetings reviewing process performance quality trends and continuous improvement technical assessment and risk evaluation support for change controls deviations investigations and process & Team DevelopmentMentor engineers and technical staff in PPV CPV methodologies statistical analysis and continuous improvement SOPs training curricula and technical standards supporting lifecycle process a culture of operational excellence accountability and proactive quality organizational capability building across MS&T and manufacturing degree in Engineering Pharmaceutical Sciences Biotechnology or related technical discipline degree preferred (MS MBA MSEM or equivalent).Experience10 years of experience in pharmaceutical biologics or sterile injectable manufacturing experience in MS&T Technical Operations Process Engineering or Manufacturing Support expertise in Continued Process Verification (CPV) statistical process monitoring and process lifecycle supporting sterile injectable aseptic processing and fill-finish leading deviation investigations CAPA change management and continuous improvement understanding of FDA Process Validation guidance GMP compliance and regulatory within a CDMO and/or external manufacturing environment with biologics vaccines CGT or complex injectable products strongly CompetenciesContinued Process Verification (CPV)Statistical Process Control (SPC)Process Trending & Data AnalyticsAseptic Processing & Sterile ManufacturingFill-Finish OperationsVisual Inspection TrendingProcess Validation & Cleaning ValidationDeviation Investigations & CAPALean Manufacturing / Continuous ImprovementRisk Assessments & FMEAGMP Compliance & Inspection ReadinessChange ManagementManufacturing Data Systems & KPI DevelopmentTechnical Writing & Regulatory DocumentationPreferred Systems & ToolsJMP Minitab Spotfire Power BI or similar statistical/trending platformsMES DeltaV PI Historian SAP TrackWise VEEVA or equivalent systemsKnowledge of automation and digital manufacturing systems#LI-Onsite