Serialization Engineer

Must Have Technical/Functional Skills

Pharmaceutical Serialization & Track and Trace; Level 2 (Line) and Level 3 (Site) Serialization Systems; GS1

Standards (GTIN, SSCC, EPCIS); DSCSA / EU FMD Regulatory Requirements; Packaging Line Integration

(Printers, Vision Systems, Aggregation); GxP & Computer System Validation; Incident, Change & Release

Management; Production Support.

Roles & Responsibilities

We are looking for a Serialization Engineer to support a pharmaceutical manufacturing customer's packaging

serialization and track-and-trace program. The engineer will be responsible for upgrading, supporting, and

enhancing serialization systems across packaging lines, ensuring that product is serialized, aggregated, and

reported in line with global regulations. The role works closely with packaging operations, quality, validation,

IT, and external partners to keep serialization systems stable, compliant, and efficient.- Upgrade, configure, and support serialization solutions (Level 2 line control and Level 3 site server) across

packaging lines and sites.- Support serialization equipment on packaging lines, including printers, vision inspection systems, and

aggregation stations.- Manage serialization master data, including GTIN, product, and batch setup, and serial number requests.- Monitor data flows and resolve reconciliation, data quality, and reporting issues.- Provide 24x7 production support, including incident, problem, change, and release management.- Support new product launches, line qualification, and changes to market regulations.- Perform root-cause analysis and troubleshooting across line equipment, software, network, and database

issues.- Prepare and execute validation and change control documentation in line with GxP and computer system

validation practices.- Work with manufacturing, quality, validation, IT, and vendor teams to resolve issues and deliver

enhancements.- Ensure adherence to GxP regulations and pharmaceutical compliance requirements.- Drive continuous improvement, automation, and documentation of serialization processes.

Salary Range: $95,000- $120,000 a year

TCS Employee Benefits Summary:

Discretionary Annual Incentive.

Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.

Family Support: Maternal & Parental Leaves.

Insurance Options: Auto & Home Insurance, Identity Theft Protection.

Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.

Time Off: Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

#LI-SP1

Desired Candidate Profile