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Commissioning, Qualification, and Validation Specialist

2 months ago

Summit, United States Rangam Full time

Pay Scale: $40 - $45 Per hour


Minimum 50% onsite required

Essential Functions:

  • Support Lifecycle Document Management System
  • Develops protocols, and associated reports while adhering to a change management process.
  • Supports the execution of equipment qualifications and validation protocols
  • Supervises vendors for qualification functions.
  • Develops written procedures for calibration and preventive maintenance of equipment
  • Supports calibration, equipment qualification and validation activities.
  • Configures and documents the configuration of computerized systems
  • Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
  • Manages projects of varying scope and complexity.
  • Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
  • Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
  • Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
  • Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
  • Provides excellent customer service and support.
  • Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
  • Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
  • Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Required Competencies-Knowledge, Skills, and Abilities:

  • Strong critical thinking skills.
  • Ability to learn and function in a fast paced environment
  • Experience executing qualification documents
  • Ability to interact effectively with laboratory, QA, and Facilities groups
  • Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
  • Ability to effectively manage multiple tasks and activities simultaneously
  • Strong written and verbal communication skills along solid presentation skills.
  • Proficient at writing well-formulated emails and reports.
  • Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
  • Ability to effectively communicate with employees, contractors and vendors.
  • Experience with technical writing and document development / generation
  • Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Competencies:

  • Technical / Professional Knowledge
  • Problem Solving / Troubleshooting
  • Action Oriented
  • Attention to Detail
  • Multi-tasking
  • Building Relationships

Education & Experience:

  • BS degree in Engineering / Computer Science or equivalent

Working Conditions:

  • Environment may include working in office or in a laboratory / manufacturing area.
  • Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
  • Ability to work safely when working alone, or working with others.