Sr Serialization Engineer
Fresenius SE & Co. KGaA, Raleigh, NC, United States
Job Summary
The Senior Serialization Engineer is responsible for the conceptual design, implementation, and validation of serialization and packaging systems across multiple capital and compliance projects — including, but not limited to, RFID solutions, cartoners, labelers, case packers, and palletizers. The role leads full project lifecycle execution, encompassing planning, scheduling, resource allocation, technical delivery, and project closure, while ensuring adherence to defined scope, timelines, and budgetary constraints. As the primary subject matter expert for Level 2/3 serialization systems, the Senior Engineer troubleshoots system issues, deploys patches and corrective actions, and ensures ongoing system lifecycle maintenance in alignment with xGMP, Data Integrity, and Computer System Validation (CSV) requirements.
Salary Range: $105,000 - $125,000
Position is eligible to participate in a bonus plan with a target of 6% of the base salary
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Benefits are comprehensive: 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits including medical, prescription drug, dental and vision coverage.
Responsibilities
Leads the conceptual design, implementation, and validation of serialization and packaging systems across capital and compliance projects (including, but not limited to, RFID, cartoners, labelers, case packers, and palletizers).
Manages full project lifecycle activities including planning, scheduling, resource allocation, execution, and closure while ensuring adherence to scope, timeline, and budget requirements.
Acts as the primary subject matter expert (SME) for Level 2/3 serialization systems, performing system troubleshooting, root-cause analysis, corrective actions, and patch deployments in accordance with xGMP requirements and CSV practices.
Evaluates, compares, and technically assesses proposed serialization and packaging solutions, including benchmarking technologies available in the market.
Conducts feasibility studies for new conceptual projects and prepares detailed time, cost, and resource analyses to support go
o-go decisions.
Ensures all projects comply with applicable State, Federal, and local regulations including FDA requirements, environmental regulations, OSHA, hazardous materials handling, and company safety standards.
Coordinates engineering activities among OEM equipment suppliers, system integrators, and validation contractors to eliminate conflicts and ensure safe and compliant execution.
Authors and approves User Requirement Specifications (URS) and participates in design reviews, risk assessments, and engineering change processes.
Develops and executes FAT, SAT, IOQ (IQ/OQ), PQ, change controls, risk assessments, and other CSV/cGMP validation protocols and lifecycle documentation.
Supports the preparation of deviation reports, CAPA actions, non-conformances, and audit responses related to serialization or packaging equipment/systems.
Interfaces cross-functionally with Packaging Engineering, Operations, IT/OT, Quality Assurance, Validation, Supply Chain, and Regulatory Affairs to ensure system readiness for commercial production.
Ensures adherence to industry standards such as GS1, EPCIS, GS1 TDS, DSCSA, EU-FMD, GAMP5, 21 CFR Part 11, ALCOA+ Data Integrity, and company internal SOPs.
Oversees equipment lifecycle activities including installation, commissioning, qualification, maintenance patching, and decommissioning.
Supports personnel training on serialization and packaging systems to ensure correct system usage and compliance.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Job Requirements
Bachelor’s degree required; preferably in Electrical Engineering, Computer Engineering, or a related technical discipline
Minimum of 5 years of relevant industry experience
Deep understanding of serialization system architectures (Levels 1–5) and integration between Level 2 equipment and Level 3 enterprise systems
Hands‑on experience with serialization platforms such as Systech, PCE, Wipotec, Antares, Optel, or comparable systems
Familiarity with packaging line equipment, including cartoners, case packers, palletizers, wrappers, labelers, and vision systems
Knowledge of vision system technologies and vendors (e.g., Cognex, Wipotec/SMC, Antares, Optel, PCE)
Ability to read and interpret mechanical and electrical drawings, P&IDs, and system design documentation
Strong understanding of IT/OT interfaces, including OPC UA, MQTT, SQL databases, and XML/EPCIS messaging
Working knowledge of DSCSA requirements and EPCIS data exchange standards
Understanding of FDA cGMP regulations, 21 CFR Part 11, and GAMP5 system validation frameworks
Knowledge of Data Integrity principles (ALCOA+), Computer System Validation (CSV), and audit expectations
Experience supporting QA/Validation activities, including IQ/OQ/PQ, CAPA, and Change Control processes
Proven ability to manage multiple projects simultaneously in a fast‑paced environment
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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The Senior Serialization Engineer is responsible for the conceptual design, implementation, and validation of serialization and packaging systems across multiple capital and compliance projects — including, but not limited to, RFID solutions, cartoners, labelers, case packers, and palletizers. The role leads full project lifecycle execution, encompassing planning, scheduling, resource allocation, technical delivery, and project closure, while ensuring adherence to defined scope, timelines, and budgetary constraints. As the primary subject matter expert for Level 2/3 serialization systems, the Senior Engineer troubleshoots system issues, deploys patches and corrective actions, and ensures ongoing system lifecycle maintenance in alignment with xGMP, Data Integrity, and Computer System Validation (CSV) requirements.
Salary Range: $105,000 - $125,000
Position is eligible to participate in a bonus plan with a target of 6% of the base salary
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Benefits are comprehensive: 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits including medical, prescription drug, dental and vision coverage.
Responsibilities
Leads the conceptual design, implementation, and validation of serialization and packaging systems across capital and compliance projects (including, but not limited to, RFID, cartoners, labelers, case packers, and palletizers).
Manages full project lifecycle activities including planning, scheduling, resource allocation, execution, and closure while ensuring adherence to scope, timeline, and budget requirements.
Acts as the primary subject matter expert (SME) for Level 2/3 serialization systems, performing system troubleshooting, root-cause analysis, corrective actions, and patch deployments in accordance with xGMP requirements and CSV practices.
Evaluates, compares, and technically assesses proposed serialization and packaging solutions, including benchmarking technologies available in the market.
Conducts feasibility studies for new conceptual projects and prepares detailed time, cost, and resource analyses to support go
o-go decisions.
Ensures all projects comply with applicable State, Federal, and local regulations including FDA requirements, environmental regulations, OSHA, hazardous materials handling, and company safety standards.
Coordinates engineering activities among OEM equipment suppliers, system integrators, and validation contractors to eliminate conflicts and ensure safe and compliant execution.
Authors and approves User Requirement Specifications (URS) and participates in design reviews, risk assessments, and engineering change processes.
Develops and executes FAT, SAT, IOQ (IQ/OQ), PQ, change controls, risk assessments, and other CSV/cGMP validation protocols and lifecycle documentation.
Supports the preparation of deviation reports, CAPA actions, non-conformances, and audit responses related to serialization or packaging equipment/systems.
Interfaces cross-functionally with Packaging Engineering, Operations, IT/OT, Quality Assurance, Validation, Supply Chain, and Regulatory Affairs to ensure system readiness for commercial production.
Ensures adherence to industry standards such as GS1, EPCIS, GS1 TDS, DSCSA, EU-FMD, GAMP5, 21 CFR Part 11, ALCOA+ Data Integrity, and company internal SOPs.
Oversees equipment lifecycle activities including installation, commissioning, qualification, maintenance patching, and decommissioning.
Supports personnel training on serialization and packaging systems to ensure correct system usage and compliance.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
Job Requirements
Bachelor’s degree required; preferably in Electrical Engineering, Computer Engineering, or a related technical discipline
Minimum of 5 years of relevant industry experience
Deep understanding of serialization system architectures (Levels 1–5) and integration between Level 2 equipment and Level 3 enterprise systems
Hands‑on experience with serialization platforms such as Systech, PCE, Wipotec, Antares, Optel, or comparable systems
Familiarity with packaging line equipment, including cartoners, case packers, palletizers, wrappers, labelers, and vision systems
Knowledge of vision system technologies and vendors (e.g., Cognex, Wipotec/SMC, Antares, Optel, PCE)
Ability to read and interpret mechanical and electrical drawings, P&IDs, and system design documentation
Strong understanding of IT/OT interfaces, including OPC UA, MQTT, SQL databases, and XML/EPCIS messaging
Working knowledge of DSCSA requirements and EPCIS data exchange standards
Understanding of FDA cGMP regulations, 21 CFR Part 11, and GAMP5 system validation frameworks
Knowledge of Data Integrity principles (ALCOA+), Computer System Validation (CSV), and audit expectations
Experience supporting QA/Validation activities, including IQ/OQ/PQ, CAPA, and Change Control processes
Proven ability to manage multiple projects simultaneously in a fast‑paced environment
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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