E Solutions

E Solutions

GMP Engineer

Indianapolis, IN (MEP-SOL)

Sponsorship not specified$20k-$30kDetected 29 days ago
ExcelGMPFDA RegulatoryCollaborationProblem SolvingWritingMicrosoft Office

About the role

  • Work Environment - Office and engineering environment with occasional work at industrial or manufacturing facilities. - Collaboration with engineering, validation, and regulatory teams on complex project environments.

Responsibilities

  • Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
  • Ensure equipment and systems are installed correctly and operate according to design specifications.
  • Maintain detailed documentation related to commissioning and qualification activities.
  • Maintain knowledge of industry regulations including FDA, GMP, and GAMP guidelines.
  • Develop and maintain validation procedures aligned with regulatory requirements.
  • Support internal and external audits related to system validation and regulatory compliance.
  • Develop and implement corrective and preventive actions (CAPAs).
  • Perform risk assessments to identify potential system performance issues.

Requirements

  • Bachelor's degree in Engineering, Science, Business, Management, or a related field.
  • Minimum of five (5) years of experience in commissioning, validation, or qualification within a regulated manufacturing or industrial environment.
  • Strong understanding of GMP, GAMP, and FDA regulatory standards.
  • Experience executing IQ, OQ, and PQ protocols.
  • Proficiency in Microsoft Office applications including Excel, Word, Outlook, and Visio.
  • Ability to work independently as well as collaboratively in cross-functional teams.
  • Collaborate with clients, vendors, and suppliers to ensure systems and equipment meet required specifications.
  • Strong technical writing and documentation skills.
  • Excellent problem-solving and troubleshooting abilities.
  • Travel Requirements
  • Ability to travel approximately 20-30% to customer locations or project sites as needed.
  • Physical Requirements
  • Prolonged periods of sitting while working at a desk or computer.
  • Ability to occasionally lift up to 15 pounds.
  • Ability to travel and work at various project or client sites.

Compensation

  • $20k-$30k
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This listing is sourced directly from E Solutions's careers page and normalized into a canonical job model.