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Principal Specialist, Process & Technology

Req #: 1700758
Location: Warren, NJ US
Job Category: Manufacturing/Technical Operations
Work Location: 7 Powder Horn Drive WARREN 07059
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Warren

Description

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.

Purpose and Scope of Position

The Principal Specialist, Process & Technology is responsible for the coordination and execution of manufacturing support of Oracle EBS 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 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 interpret / write technical documents
  • Ability to solve routine and complex problems

Duties and Responsibilities

Assist in designing, testing, and maintaining the EBR and related manufacturing data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, formulas, process instructions, and process variables.

  • Collaborate within the P&T department and with manufacturing, quality control, quality assurance, IT, global master data management, and PPIC personnel to determine business requirements for the design of master data.
  • Translate business requirements into a robust data design which is compliant, efficient, and effective.
  • Collaborate with peers to develop new SQL process variables required for electronic batch records by providing detailed business requirements.
  • Coordinate the testing of master data with peers and internal customers to ensure business requirements are achieved.
  • Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable batch records and supporting data. 
  • Develop and execute cGMP change controls and ServiceNow change requests for master data changes.
  • Provide department representation on site projects.
  • Collaborate with other stakeholders (global and site) to maintain and optimize product hierarchy while maintaining compliance and minimizing risk.
  • Perform other tasks as assigned.

Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.

  • Develop and provide technical training to Oracle EBS users.
  • Maintain an understanding of the manufacturing processes and Oracle EBS.
  • Provide periodic on-call support to internal customers for emergent system issues.
  • Troubleshoot routine and complex problems to support internal customers.
  • 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.

Working Conditions

  • 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

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.

#LI-POST

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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