External Manufacturing Project Specialist

About the Role

This role drives compliant global product launches, handles quality events, coordinates daily system operations, and leads validation activities across global markets. The role collaborates with internal teams and external partners (CMOs, 3PLs, EMVOs) to ensure end-to-end serialization and track-and-trace readiness.

Location: East Greenbush, New York, United States

Work Schedule: Monday-Friday, 8:00 AM - 4:30 PM

Key Responsibilities

• Ensure serialization readiness for new and transferred products, including market-specific DSCSA, EU-FMD, and ROW requirements.
• Coordinate supporting documents and attributes for labeling, GTINs/SSCCs, aggregation strategies, and master data alignment with CMOs/3PLs.
• Complete readiness checks, input-output qualification runs, and planning with Project Managers.
• Support investigations and documentation for validations, deviations, nonconformances, complaints, EOEs, CCs, and CAPAs.
• Maintain audit-ready records and ensure timely closure in accordance with internal QMS and regulatory standards.
• Implement corrective actions, risk assessments, and mitigation plans.
• Operate and coordinate track-and-trace platforms (e.g., Tracelink): user access, master data, partner connections, EPCIS/EDI message monitoring, and exception handling.
• Troubleshoot data flow issues (commissioning, aggregation, decommissioning) to minimize supply disruptions.
• Plan and implement CSV activities (IQ/OQ/PQ), test scripts, and evidence collection for serialization systems and integrations.
• Support technical transfers by aligning serialization requirements, artwork changes, and site configurations.
• Own change controls and configuration baselines across systems and partners.
• Serve as liaison with CMOs, 3PLs, and EMVOs to resolve serialization issues and maintain required operations.
• Communicate timelines, risks, and results; drive cross-functional alignment with Supply Chain Project Managers.
• Apply PM techniques to scope, schedule, and deliver well-defined EM sub-projects.
• Track progress and report status to ensure timely execution.

Requirements & Tech Stack

• Hands-on experience with track-and-trace systems (e.g., Tracelink) and partner connectivity.
• Proven support for investigations and quality events (deviations, EOEs, CCs, CAPAs).
• Demonstrate project management skills.
• Experience leading end-to-end serialization implementations and product launches.
• Strong knowledge of DSCSA, EU-FMD, and ROW requirements.
• Familiarity with global standards and emerging regulations preferred.

Qualifications

• BS/BA in Engineering, Supply Chain, or Life Sciences.
• Related experience in pharma/biotech serialization, packaging, and labeling.
• Associate Specialist: 0-2 years
• Specialist: 2+ years
• Sr Specialist: 5+ years

Level will be determined based on experience.