Computer System Validation Manager Jobs in Missouri

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

We are seeking an experienced Senior Manufacturing Engineer to lead technical operations and process optimization in our state-of-the-art Assembly, Inspection, and Packaging plant. In this critical role, you will drive manufacturing excellence for pharmaceutical products (sterile and non-sterile) while ensuring full compliance with cGMP, FDA, EMA, and other regulatory requirements.

As a senior technical leader, you will be responsible for equipment performance, process robustness, continuous improvement, new product introductions (NPI), Tech Transfers in high-speed automated inspection, assembly and packaging lines.

Key Responsibilities

• Lead the design, qualification, and optimization of visual inspection, assembly, labeling, and packaging processes for vials, syringes, cartridges, auto-injectors, and other pharmaceutical delivery devices.
• Develop and maintain process flow diagrams, equipment specifications, and critical process parameters (CPPs).
• Identify and implement process improvements using Lean, Six Sigma, and data-driven methodologies to increase throughput, yield, and equipment effectiveness (OEE).
• Lead capital and continuous improvement projects from concept through implementation, including scope definition, URS development, vendor engagement, FAT/SAT support, commissioning, qualification, and handoff to operations.
• Troubleshoot complex manufacturing issues related to high-speed automation, vision systems, robotics, and serialization/track-and-trace systems.

• Lead by example in safety, environmental, and compliance practices; identify and mitigate operational risks in manufacturing processes and equipment.

• Author, execute, and review validation protocols (IQ/OQ/PQ, process validation, and computer system validation) for new and existing equipment.
• Ensure all manufacturing processes remain in a validated state and comply with 21 CFR Parts 210/211, Annex 1, and ISO standards.
• Support regulatory inspections (FDA, EMA, etc.) and internal audits as a subject matter expert (SME) for IAP processes.
• Lead deviation investigations, CAPA implementation, and change control activities.
• Serve as the primary manufacturing engineering lead for technology transfers and scale-up of new products into the IAP plant.
• Collaborate with Process Development, Quality Assurance, and Regulatory Affairs to ensure manufacturability and compliance.
• Support design for manufacturability (DFM) reviews during product development.

• Evaluate, select, and implement new assembly, packaging and inspection technologies (e.g., automated visual inspection systems, high-speed labelers, cartoners, case packers).
• Manage equipment reliability programs, including preventive maintenance optimization and spare parts strategy.
• Work closely with Reliability, Maintenance and Automation Engineering teams on equipment uptime and performance.

• Mentor and provide technical guidance to junior Manufacturing Engineers and technicians.
• Lead cross-functional teams on major projects and Kaizen events.
• Drive OEE improvement initiatives and cost reduction programs.
• Prepare technical reports, presentations, and documentation for leadership and clients

Qualifications & Requirements

• Bachelor’s degree in Mechanical, Chemical, or Industrial Engineering, or a related technical field; master’s degree preferred.
• Minimum 6+ years of experience in pharmaceutical or biotechnology manufacturing, with at least 2 years in a Senior Engineer or equivalent role.
• Strong experience in Assembly, Inspection, and Packaging of sterile injectables or complex drug-device combination products is required.
• Proven track record with high-speed automated packaging lines, vision inspection systems, and serialization systems.

• Deep knowledge of cGMP, validation principles (GAMP 5 – Risk Based approach to compliant GxP design and systems), and pharmaceutical regulatory requirements.
• Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis tools (FMEA, Fishbone, etc.).
• Proficiency in reading technical drawings (P&ID, mechanical layouts) and working with CAD software.
• Familiarity with Track-and-Trace, 2D coding, and anti-counterfeiting technologies.
• Lean Six Sigma Green Belt or Black Belt certification is highly desirable.

• Strong leadership and project management skills.
• Excellent technical writing and communication abilities.
• Ability to thrive in a fast-paced, client-focused CDMO environment.

Preferred Qualifications

• Experience supporting commercial manufacturing for large pharmaceutical clients.
•  Knowledge with integrated packaging systems such as feeders, labelers, cartoners, checkweighers, case packers, reject systems, vision inspection, and serialization/aggregation platforms preferred.Previous experience in a multi-product CDMO facility.
• Project management certification (PMP) or equivalent.

What We Offer

• Competitive base salary + performance bonus
• Comprehensive benefits package (health, dental, vision, 401k, etc.)
• Professional development and conference opportunities
• Exposure to cutting-edge pharmaceutical manufacturing technologies
• Collaborative and innovative work culture

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