Project Manager I #JN -022021-60343
Murrysville, Pennsylvania
Posted on: February 23, 2021
Industry: Business Analyst / Project Manager
Job Number: JN -022021-60343
Description:
- Support Product Lifecycle Data (PLDM) team in delivering compliant change packages in an electronic data management system (SAP). Work closely with Engineering, Regulatory, Project Management, and other cross-functional teams to prepare Engineering Change Request (ECR) packages and support Customer Master Data functions
Education/Experience:
- Bachelor’s Degree or equivalent
- 3+ years’ experience managing projects of varying complexity
- Proficient in Microsoft Office applications (Excel, Word, PowerPoint)
- Proficient SAP or equivalent. Knowledge of Configuration Management principles
Material Master Management:
- Create and change material masters as required
- Extend part numbers into SAP to support multiple manufacturing facilities and engineering change activities
- Understand required settings to obsolete parts/ BOMs/ documents (including material implications)
- Provide guidance in trouble-shooting and driving resolution of Material Master issues
Document Management:
- Review and approve documents for completeness and format accuracy prior to release
- Understand document signature strategies
- Complete document linkage at appropriate time
- Ability to decipher information from generated reports
- Review and approve Quality System Documents
- Ability to retrieve historical information from current and legacy systems
- Provide guidance in trouble-shooting and driving resolution of Document Management issues
ECR/ECO Management:
- Support the creation of FDA compliant ECO packages for all changes of varying complexity including new product introductions utilizing Configuration Management principles
- Work in cross-functional ECO related activities in order to meet agreed upon deadlines
- Identify and assist in resolution of roadblocks preventing release of change notices
- Determine appropriate part numbers/BOM Structures prior to release (assist in BOM review activities)
- Support Pilot Run activities
- Support change notices in SAP (releasing parts BOMs and production documents)
- Ability to understand need and use for different BOM set ups (example: active, engineering, alternates)
- Ability to review ECR / ECO hierarchy / content and understand requirements and use
- Create and maintain lot tracking
- Ability to manage Electronic Device History Record activities, as needed
- Provide guidance in trouble-shooting and driving resolution of ECR/ECO Management issues
Training:
- Guide and assist peers in job function areas as needed
- Facilitate training internal and external to the PLDM Department
- Contribute to the development of necessary training materials
Project Management:
- Support ECO activities as described above
Cross functional Support - Training Administrator duties
- Administer training to production associates
- Provide training materials to new hires, as part of an onboarding process
- Ensure production associates are trained to new changes to process / product
- Maintain updates to roles in Training Management System (TMS)
- Distribute & retrieve latest documents to production
- Notify production associates of changes and circulate for recertification
- Provide feedback to users on profile and training compliance and non-compliance
- Support users on using the Training Management System
- Establish, monitor and respond to metrics on the efficacy and efficiency of the Training Administration and Control activities and its ability to support the business