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Serialization Manager Jobs in High Ridge, MO (NOW HIRING)

kindeva

Manager, Packaging Operations

Saint Louis, MO · On-site

Experience supporting automated packaging systems, labeling, cartoning, serialization, packaging ... manage multiple priorities, drive accountability, and effectively interact with customers ...

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Serialization Manager information

See High Ridge, MO salary details

$22.4K

$54.4K

$105.9K

How much do serialization manager jobs pay per year?

As of May 31, 2026, the average yearly pay for serialization manager in High Ridge, MO is $54,356.00, according to ZipRecruiter salary data. Most workers in this role earn between $38,400.00 and $62,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Serialization Manager, and why are they important?

To thrive as a Serialization Manager, you need in-depth knowledge of pharmaceutical supply chain regulations, serialization processes, and compliance standards, typically supported by a degree in a scientific, engineering, or related field. Familiarity with serialization software (such as SAP ATTP, TraceLink), data management systems, and regulatory compliance tools is crucial. Strong project management, problem-solving skills, and effective communication enable successful cross-functional collaboration and issue resolution. These skills and qualifications are vital to ensure products meet regulatory requirements, prevent counterfeiting, and maintain supply chain integrity.

How does a Serialization Manager typically interact with cross-functional teams to ensure compliance with global pharmaceutical regulations?

A Serialization Manager regularly collaborates with quality assurance, IT, supply chain, and regulatory affairs teams to ensure all serialized products meet global regulatory requirements. This includes coordinating system integrations, aligning on data standards, and troubleshooting issues that could impact product traceability. Effective communication and project management skills are essential, as the role often requires leading cross-functional meetings, providing training, and ensuring any changes in regulations are quickly implemented across all departments involved in the serialization process.

What does a Serialization Manager do?

A Serialization Manager oversees the process of assigning unique serial numbers to products, typically in the pharmaceutical or manufacturing industries, to ensure traceability and compliance with regulatory requirements. They manage serialization systems, coordinate with IT and production teams, and ensure all products are properly serialized and tracked throughout the supply chain. Their role is crucial for preventing counterfeiting, supporting product recalls, and meeting government regulations.
Serialization Manager jobs near you
Director, Automation Engineering & CSV

Director, Automation Engineering & CSV

Kindeva Drug Delivery

Bridgeton, MO • On-site

Full-time

Posted 4 days ago

Job description

Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
Why Kindeva?
  • Purpose-driven work environment
  • Significant growth potential
  • Collaborative team culture
  • Direct impact on patient care
  • Industry-leading innovation

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make:
Lead the Future of Pharmaceutical Automation. Join a growing pharmaceutical CDMO where your leadership will establish and standardize automation strategy across three manufacturing sites with varying automation maturity. You will serve as the enterprise automation leader responsible for new facility stand-up, all supporting and filling equipment, automated visual inspection systems, auto-injector and device assembly automation, packaging integration, serialization, and full lifecycle system ownership from specification through commercialization.
You will combine deep pharmaceutical automation expertise with strong organizational leadership to build a scalable, sustainable automation program that supports operational excellence, regulatory compliance, and long-term talent development. This is a highly visible leadership role with significant impact across multiple sites and functions.
Responsibilities:
Enterprise Automation Strategy
  • Standardize controls architecture, PLC/HMI platforms, data systems, and automation governance.
  • Establish a robust lifecycle management program aligned with GAMP and regulatory expectations.
  • Lead modernization initiatives for legacy systems while ensuring minimal operational disruption.

New Facility & Capital Project Leadership
  • Lead automation strategy for major expansion projects.
  • Own development and oversight of URS, FS, DS, FAT/SAT, commissioning, qualification, and PPQ support.
  • Drive seamless integration from equipment procurement through validated commercial launch.
  • Provide technical oversight during capital justification and vendor selection processes.

Fill-Finish & Inspection Automation
  • Provide subject matter expertise in:
  • Automated visual inspection (AVI) for syringes and vials
  • Cosmetic and particulate detection technologies
  • Reject management and data capture systems
  • Ensure inspection systems meet global regulatory and data integrity expectations.

Auto-Injector & Combination Product Automation
  • Lead automation oversight for auto-injector and specialty device assembly systems, including:
  • Automated visual inspection (AVI) for syringes and vials
  • Needle safety system integration
  • Plunger rod insertion and final device assembly
  • Functional device testing (force, timing, deployment verification)
  • Traceability and tamper-evident integration
  • Ensure compliance with combination product regulatory requirements.

Packaging, Serialization & Specialty Packaging
  • Oversee packaging automation platforms including:
  • Multi-carton configurations
  • Blister packaging
  • Specialty packaging for combination products
  • Auto-injector final pack-out systems
  • Serialization and aggregation (unit through pallet).
  • Ensure compliance with DSCSA, EU FMD, and global track-and-trace requirements
  • Integrate packaging and serialization systems with enterprise data platforms.

Lifecycle & Commercialization Ownership
  • Provide automation leadership from concept through commercialization.
  • Partner with Validation and Quality to ensure compliant IQ/OQ/PQ execution.
  • Drive automation reliability, performance monitoring, and OEE optimization.
  • Implement structured change control and digital lifecycle documentation practices.

Multi-Site Technical Oversight
  • Harmonize automation standards across three sites.
  • Establish standardized spare parts strategies and obsolescence management.
  • Provide escalation leadership for critical automation events.
  • Define modernization roadmaps based on risk and operational impact.

Organizational Development & Talent Strategy
  • Build and lead a high-performing automation engineering organization.
  • Develop structured onboarding and certification pathways for new engineers.
  • Implement cross-training frameworks to ensure operational redundancy.
  • Establish a formal succession planning and competency development program.
  • Create a sustainable staffing model balancing capital project demand and operational support.

Compliance & Data Integrity
  • Ensure compliance with:
  • 21 CFR Part 11
  • Annex 11
  • GAMP 5 lifecycle standards
  • Combination product regulatory guidance.
  • Maintain audit readiness across automation systems and digital infrastructure.
  • Partner with IT/OT to strengthen cybersecurity and system resilience.

Qualifications:
Required
  • Bachelor's degree in Engineering or related technical field required; Master's degree preferred.
  • 10+ years of progressive pharmaceutical automation experience.
  • Demonstrated success leading automation for new fill-finish or device manufacturing facilities.
  • Strong experience in validation, commissioning, and commercialization support.
  • Proven leadership experience in building and developing automation teams.

Preferred
  • Deep expertise in:
  • Automated visual inspection (vials and syringes)
  • Auto-injector assembly and device automation
  • Formulation, filling, inspection and packaging automation and serialization systems
  • Multi-site automation leadership

Core Competencies
  • Pharmaceutical fill-finish automation
  • Combination product and device assembly automation
  • Packaging & serialization integration
  • PLC, SCADA, HMI, MES architecture
  • Lifecycle validation and data integrity
  • Multi-site standardization
  • Organizational development & succession planning
  • Strategic capital execution

Physical Requirements
  • Employees are required to follow all cGMP and safety procedures.
  • Must wear all required PPE and perform assigned work in a safe manner.
  • Must use proper lifting techniques and be aware of hazards in the environment.
  • Vision requirements include close, distance, color vision, and focus adjustment.

Impact of the Role
This position will define and institutionalize a long-term, robust automation program across three manufacturing sites. The leader in this role will ensure scalable, compliant, and technically advanced manufacturing systems capable of supporting complex fill-finish operations and combination products
Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.
# LI-Onsite
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

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