Biopharmaceutical Automation Specialist

3 weeks ago


Reston, Virginia, United States Intellectt Inc Full time

We are seeking a highly skilled Automation Validation Engineer to play a key role in the successful launch of our new state-of-the-art biopharmaceutical manufacturing facility at Intellectt Inc. As a member of our team, you will have the opportunity to work on cutting-edge technologies and make a meaningful impact in the fast-growing biotechnology industry.

Key Responsibilities:

  • Collaborate with cross-functional teams to ensure seamless startup operations, including IO checks, system integration, and validation activities.
  • Provide technical expertise to OEM engineers, facilitating smooth system integration and ensuring compliance with industry standards.
  • Participate in Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ) phases to guarantee efficient validation processes and ensure the facility is ready for production.
  • Execute comprehensive test protocols, manage change controls, and address any exceptions that arise during the validation process.
  • Manage system backups, configure user groups, and develop training documentation for end-users to ensure a smooth transition to production.

Requirements:

  • Bachelor's degree in Electrical Engineering, Chemical Engineering, or a related field.
  • Proven experience in FDA-regulated environments, specifically in biotech, pharmaceutical, or medical device industries.
  • In-depth knowledge of automation technologies, electrical control systems, and computer system validation (CSV).
  • Familiarity with upstream and downstream biopharmaceutical processes.
  • Proficiency in industry-leading tools such as Studio 5000 Logix Designer, FTView SE, and FTView ME.

Ideal Candidate:

  • Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.
  • Excellent communication and collaboration abilities, with the ability to work effectively in a fast-paced environment.


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