Demo

Change control engineer

i-Pharm Consulting
Rocky, NC Temporary
POSTED ON 3/27/2025
AVAILABLE BEFORE 4/24/2025

Change Control Specialist | W2 Contract | Initial Term Until December 2025

We are looking for an experienced Change Control Specialist to join a key project with a top pharmaceutical company on a 12-month W2 contract, with the potential for extension based on performance and project needs.

This critical project involves replacing an existing filling line, encompassing the removal of outdated equipment, installation of new machinery, and reconnection to facilities and utilities. Your primary responsibility will be to manage change control activities, ensuring seamless coordination and allowing the CQV team to focus on equipment qualification.

Primary Responsibilities

  • Lead and manage change control processes for equipment, utilities, and facilities throughout the line replacement project.
  • Collaborate effectively with Process Engineering and CQV teams to maintain project alignment and operational efficiency.
  • Ensure all change control documentation complies with GMP requirements within a sterile / aseptic manufacturing setting.

Key Project Scope

  • Equipment :
  • Unscramblers, washers, depyrogenation tunnels, fillers, stoppers, RABs, cappers, tray loaders.
  • Facilities :
  • Airlocks, electrical / mechanical rooms, wet rooms, vial preparation areas.
  • Utilities :
  • WFI, nitrogen systems, chilled water, floor drains, compressed air.
  • Qualifications

  • Demonstrated experience managing change controls in GMP-regulated, sterile, or aseptic environments.
  • Familiarity with the equipment and facilities listed above.
  • Proficiency with TrackWise is highly desirable.
  • Prior experience working with Pfizer or similar organisations is an advantage.
  • This is a fantastic opportunity to contribute to a high-profile initiative with a leading pharmaceutical company. If you have the expertise and drive to succeed in managing complex change control processes, we encourage you to apply today!

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