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Engineer II (Maintenance GMP experience)
6 days ago
Contract
Rahway, New Jersey, US

Job Description

Qualifications:
  • Education and Work Experience: Bachelor’s degree in engineering / science - required. 1-5 yrs. relevant experience (Co-op/internship and real world).
  • Ideal candidate is comfortable in a lab, familiar with quality systems, GMP experience, qualification/validation experience would be a plus.
  • Experience with safety, health & environmental procedures - preferred
  • Experience/awareness of cGMP policies and procedures - preferred
  • Experience with SAP/ProCal/Trackwise (or similar) Project Management System is a plus

Responsibilities:

  • Under the direction of Pharmaceutical Operations & Clinical Supply (Pharm Ops), responsible for providing engineering support to Pharmaceutical Sciences projects and initiatives, ensuring compliance and support primarily for the Laboratory areas but can be expanded to Pharm-Ops capital project support. This includes understanding GMP Quality systems as well as preparing and executing equipment / analytical system qualifications and validations. Primary location is RY.
  • Selected Responsibilities: Support GMP Equipment / Analytical System lifecycle
  • Qualification and validation documentation preparation and execution.
  • Calibration and Maintenance support
  • Equipment and Computer system periodic reviews
  • Change Management and Investigation support
  • Work and interact with cross-functional team members as required, in GSE, GES, GWES & MRL groups Capital Project management and administration in CCMS and CMMS computerized systems (SAP/ProCal) • CCMS – Computerized Calibration Management System (ProCal)
  • CMMS – Computerized Maintenance Management System (SAP)
  • Execute project administration activities (project creation, purchase orders, asset actions, etc.) Pharm Ops Engineering support
  • Provide miscellaneous engineering support to Pharm Ops Engineering (POE) in terms of capital project, engineering, maintenance coordination, etc.
  • Work and interact with cross-functional team members as required, in GSE, GES, GWES & MRL groups

Job Requirements

GMP experience, quality systems, Laboratory, qualification, validation, SAP, Trackwise

 

Job Code: 50119830

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Recruiter Kajal
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