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

Kindeva; Missouri; On-site; USD 140,000 - 190,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior Manager, MS&T – PPV, CPV & Operational Excellence to lead PPV/CPV activities across sterile injectable and biologics manufacturing. You will own validation lifecycle management, process performance monitoring, and CAPA execution, partnering with Manufacturing, Quality, Regulatory, Engineering, and Supply Chain to ensure compliant, inspection-ready operations.

The ideal candidate brings 10+ years in pharma manufacturing, strong expertise in CPV/PPV, SPC,

Qualifications

• Experience in MS&T, Technical Operations, or Manufacturing Support roles.
• Strong CPV and SPC experience.
• Aseptic processing and fill-finish experience.

Responsibilities

• Lead PPV/CPV activities for sterile injectable and biologic processes.
• Develop validation documents and analyze data for process capability.
• Support regulatory inspections and client audits.
• Drive continuous improvement and CAPA programs.

Skills

Process Validation

CPV & PPV

Data Analytics

CAPA & investigations

Lean Six Sigma

Regulatory Compliance

Education

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, or related

Advanced degree preferred

Tools

JMP

Minitab

Spotfire

Power BI

SAP

TrackWise

VEEVA

DeltaV

Job description

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:
• PPQ protocols and reports
• Sampling plans
• Statistical analysis plans
• 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.
• 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
• 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

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.