Share this Job
Create Alert

Sr. Analyst Serialization Systems

Date: Jul 18, 2019

Location: Wilson, NC, US, 27893

Company: Purdue Pharma L.P. & Affiliates

Working at our Company

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships.

Job Summary

Purdue & and its Independent Associated Companies are seeking a technical analyst to maintain all its serialization systems. The Sr. Analyst ensures all systems stay compliant with product identification related regulations in the US, EU and other markets, and identify opportunities to leverage serialization information for better supply chain visibility and tracking. The Sr. Analyst works closely with supply chain, regulatory & engineering teams to ensure all serialization systems meet regulatory requirements for different markets, streamline serialization related activities for new product launch, onboard new contract packagers, support launch in new markets. Knowledge of line serialization systems, and interfaces with partners or government organizations is a strong plus.

The position reports into the Global IT organization and has opportunities to go beyond serialization and learn and support systems and projects within the Quality team. The successfully candidate must be able to work independently with minimal supervision on multiple projects/support tickets and be able to adapt to changes in a dynamic business and external environment.

Primary Responsibilities
  • Technical SME for the following serialization systems-SAP ATTP, SAP ICH and Tracelink.
  • Configuration of Serialization Profile, Range Definitions, Ranges, Range Requests, triaging and correcting error messages in ATTP, Tracelink and ICH.
  • Support projects & lead small to medium serialization related projects and participate in product launches (primary focus on North Americas, but could need to extend support on a need basis to EU and Asia team)
  • Create validation documents such as Requirement, Functional and Design specifications, per requirements
  • Adhere to strong IT Governance and change control process for all changes in a FDA/EU regulated environment including validation.
  • Support the application and perform troubleshooting for issues encountered
  • Coordinate, configure & test serialization systems with 3rd party Contract Manufacturing, Brand-owners, wholesalers as part of onboarding or post go live changes/support.
  • Collaborate with software vendors such as SAP & Tracelink for application support and incident resolution
Education and Experience
  • BS/BA in Computer Science, information systems, or related field.
  • 2-3 years Serialization Experience (End to End)
  • System configuration and subject matter expert in SAP ATTP.
  • Configuration and knowledge of SAP ATTP integration with Packaging line solutions such as Systech/Optel, Tracelink, ECC and other connected systems.
  • Experience working in high pace IT support/service organization.
  • Strong understanding of GS1 standards, EPCIS message formats & HDA guidelines.
  • Experience in Project Management of small to medium size projects.
  • Pharma / Biotech (or equivalent industry) experience
  • Supply Chain or Manufacturing business process knowledge required.
Necessary Knowledge, Skills, and Abilities
  • In depth knowledge of SAP ATTP functionality & configuration.
  • Strong knowledge of serialization & Track and Trace concepts.
  • Knowledge of pharma domain and GxP processes and solution implementation in a validated environment.
  • Desire to go beyond serialization and learn other systems.
  • Knowledge of Tracelink & SAP ICH is desirable.
Supervisory Responsibilities (if Applicable)

While this position does not have direct supervisory responsibility, it may require a need to oversee the work of outside contractors. 

Additional Information

Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount

Job Segment: Systems Analyst, Biotech, Engineer, ERP, Law, Technology, Science, Engineering, Legal