Other Locations:US- NJ- Warren
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Principal Specialist, Testing & Reporting
Purpose and Scope of Position
The Principal Specialist, Testing & Reporting is responsible for the overall coordination of testing and reporting in the support of the site ERP system and associated boundary systems to maintain a compliant, effective, and efficient operation that meets or exceeds site goals and objectives.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced proficiency in Microsoft Excel
- Advanced knowledge of computerized system testing
- Advanced knowledge of SQL development
- Advanced knowledge of cGMP regulations
- Advanced written and verbal communication skills
- Advanced presentation development and delivery skills
- Advanced proficiency in Microsoft Word and Outlook
- Ability to backfill management and mentor peers
- Ability to provide training inter departmentally, site wide, and globally
- Ability to provide on-call support in case of emergent issues
- Ability to gown into Grade C and D classified environments
- Ability to work independently for extended periods of time
- Ability to work as a team
- Ability to travel < 10% of time
- Ability to interpret / write technical documents
- Ability to solve routine and complex problems
Duties and Responsibilities
Assist in the development and prioritization of testing manufacturing-related setup and data from the site ERP system and associated boundary systems.
- Collaborate with site management and IT to develop business requirements for business process improvements within global information systems.
- Coordinate with IT and other site departments to maintain supporting technologies that are compliant, efficient, effective and reliable.
- Performs business impact assessment on changes to ERP system, boundary systems, and business processes.
- Collaborate with peers, P&T, IT, and validation personnel to develop and prioritize testing of manufacturing-related ERP system and associated boundary systems.
- Collaborate with peers, P&T, IT, engineering, and validation personnel to support integration of boundary systems with the manufacturing execution system and/or ERP system in support of manufacturing processes.
- Develop risk-based testing approach by understanding how to translate business requirements into data design to ensure a compliant, efficient, and effective system.
- Collaborate with IT and other site departments to develop and maintain site test scripts and other related testing documentation.
- Collaborate with IT and other site departments to manage testing execution related to the ERP system (i.e., development testing, integration testing, user acceptance testing, regression testing).
- Understand manufacturing processes and the implementation within the global ERP and boundary systems (i.e., configuration and master data, including, but not limited to, items, recipes, routings, formulas, process instructions and process variables).
- Act as site project coordinator as required for new systems, enhancements to current systems, and/or required regression or other testing coordinated at a global level.
- Periodically on-call to provide support to manufacturing support in case of emergent system issues
- Perform other tasks as assigned.
Collaborate with peers, P&T, IT, and other site departments to develop reports for ERP system from ERP reporting tool(s).
- Collaborate with IT and other site departments to gather business requirements, prioritize, develop, design, and deliver reports from ERP reporting tool(s).
- Provides technical training to users on reporting tool(s) and ERP system.
- Perform other tasks as assigned.
Education and Experience
- Bachelor’s degree required.
- 10 years relevant work experience required, preferably in a pharmaceutical manufacturing environment.
- 2 years of experience with project coordination and cross-functional team leadership preferred.
- 2 years of experience supporting Oracle EBS or similar ERP system, preferably an MES system required.
- An equivalent combination of education, experience and training may substitute.
- The incumbent will be required to gown to access classified manufacturing areas.
Definitions and Abbreviations
- P&T: Process and Technology
- EBR: Electronic Batch Record
- EBS: Enterprise Business Suite
- cGMP: Current Good Manufacturing Practices
- MES: Manufacturing Execution System
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.