Senior MS&T Leader: PPV, CPV & Ops Excellence

Kindeva; Maryland Heights (MO); On-site; USD 150,000 - 190,000; Full time

Job summary

Kindeva is seeking a Senior Manager, MS&T - PPV, CPV & Operational Excellence to lead validation lifecycle activities for sterile injectable and biologic processes. You will oversee PPV partnerships, CPV programs, and continuous improvement while ensuring regulatory readiness and FDA-aligned practices.

You will mentor teams, drive statistical trending, and collaborate across Manufacturing, Quality, Validation, Regulatory, and Engineering to deliver inspection-ready operations in a CDMO

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, or related technical discipline.
• Advanced degree preferred (MS, MBA, MSEM, or equivalent).
• 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.

Responsibilities

• 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: CPPs, CQAs, Process performance trending, statistical justification and acceptance criteria.
• 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.
• Lead site and product-level CPV programs for sterile injectable and biologic manufacturing processes.
• Mentor engineers and technical staff in PPV, CPV methodologies, statistical analysis, and continuous improvement practices.

Skills

CPV

Statistical trending

Data analytics

CAPA

Process validation

Aseptic processing

Lean Six Sigma

GMP compliance

Education

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

Advanced degree preferred (MS, MBA, MSEM, or equivalent)

Tools

JMP

Minitab

Spotfire

Power BI

MES

DeltaV

PI Historian

SAP

TrackWise

VEEVA

Job description

Kindeva is seeking a Senior Manager, MS&T - PPV, CPV & Operational Excellence to lead validation lifecycle activities for sterile injectable and biologic processes. You will oversee PPV partnerships, CPV programs, and continuous improvement while ensuring regulatory readiness and FDA-aligned practices.

You will mentor teams, drive statistical trending, and collaborate across Manufacturing, Quality, Validation, Regulatory, and Engineering to deliver inspection-ready operations in a CDMO