Transformation Project Qualification Lead- API

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17 minutes ago
Type
Full time
Salary
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risk management api validation fmea equipment
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πŸ“‹ Description

  • Lead the EFU and Automation Qualification sub-teams on a Strategic Capital Project.
  • Accountable to the Project Director for schedule, execution, risk, and reporting.
  • Plan and complete tasks for commissioning, qualification and validation of equipment, facilities
  • Develop user requirements and functional/design specs for new or modified assets.
  • Support Factory Acceptance Testing with Project Engineer to confirm unit acceptability.
  • Implement risk management, validation master plan guidelines, and change controls.

🎯 Requirements

  • Bachelor’s Degree in Engineering or related field; 3+ years in engineering/operations.
  • Experience developing commissioning, qualification, validation deliverables for regulatory scrutiny.
  • 6+ years in Manufacturing/Quality/Engineering with multiple validation subjects.
  • Technical background in healthcare/pharma/lab/device industries preferred.
  • Strong communication and teamwork; knowledge of quality/compliance regs for API/Drug manufacturing
  • Ability to supervise junior/contract team members and manage multiple projects.

🎁 Benefits

  • AbbVie equal opportunity employer information and compliance commitments.
  • US & Puerto Rico relocation and accommodation information available.
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