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Validation Engineer

2 months ago

Boulder, Colorado, United States IPS-Integrated Project Services, LLC Full time
About the Role

We are seeking a highly skilled Validation Engineer to join our team at IPS-Integrated Project Services, LLC. As a key member of our team, you will be responsible for ensuring the compliance of our clients' facilities with Good Manufacturing Practice (GMP) regulations.

Key Responsibilities
  • Document Development: Create and maintain C/Q/V documents, including commissioning forms, protocols, and summary reports, in accordance with established standards and templates.
  • Field Activities: Perform site activities, such as attending and witnessing FATs and SATs, executing commissioning forms and witnessing vendor start-up and testing, and compiling data and preparing reports for completed C/Q/V activities.
  • System Verification: Verify system drawings, including P&IDs and as-builts, and ensure that all systems are properly qualified and validated.
  • Problem-Solving: Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Collaboration: Work closely with the Project Delivery department and other stakeholders to ensure that all projects are completed on time and within budget.
Requirements
  • Education: Bachelor of Science in Engineering.
  • Experience: Entry-level position - 0 to 2 years of relevant experience in pharmaceutical, biotech, medical device design, construction, commissioning, validation, or QA.
  • Skills: Proficiency with Microsoft Office applications, excellent communication and interpersonal skills, and ability to work in a team environment.
About IPS-Integrated Project Services, LLC

IPS is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. We provide consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.

We are proud to be an affirmative action and equal opportunity employer. We are committed to creating a diverse and inclusive work environment that values and respects all employees.