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Process Automation Specialist

2 months ago

Raleigh, North Carolina, United States Advanced Recruiting Partners Full time

Position Overview:

The Automation Systems Engineer is tasked with overseeing both current and forthcoming automation frameworks within a regulated manufacturing environment. This role includes performing daily checks to ensure data integrity and making necessary adjustments to system configurations to meet process and automation requirements.

Work Arrangement: On-site

Key Responsibilities:

  • Leverage engineering expertise to provide automation solutions for the design and development of specialized manufacturing equipment for a human acellular vessel product, under the guidance of senior team members.
  • Maintain and support the existing PI data historian across manufacturing and research facilities.
  • Collaborate with senior engineers to assist in the installation and validation of a PI data historian for the manufacturing site.
  • Contribute to the installation and validation of DeltaV systems for manufacturing processes.
  • Assist in the setup and validation of building automation systems for the production facility.
  • Support the implementation and validation of both OEM and custom PLCs for manufacturing operations.
  • Work with the process development team to test prototype equipment and independently develop automation for custom R&D equipment.
  • Ensure transparency in process development through regular updates to management and cross-functional teams.
  • Troubleshoot automation issues during development, technology transfer, and production phases.
  • Conduct comprehensive system tests to verify the reliability of custom automation solutions.
  • Assist in ensuring automated equipment meets regulatory and quality control standards.
  • Help create automation documentation, including functional requirements, design specifications, testing protocols, SOPs, and reports.
  • Respond to automation-related alerts during standard hours and provide on-call support as needed.
  • Support regulatory submissions as necessary.
  • Perform additional duties as assigned.

Essential Skills:

  • Proven experience in developing and supporting automation for manufacturing processes.
  • Familiarity with bioprocess automation in a GMP environment.
  • Understanding of cGMP compliance within the biotech manufacturing sector.
  • Knowledge of relevant federal regulations is advantageous.
  • Detail-oriented, self-driven, and scientifically focused.
  • Strong analytical and problem-solving capabilities.
  • In-depth knowledge of GMP quality systems.
  • Excellent communication and interpersonal skills.

Qualifications:

  • Bachelor's degree in Mechanical, Electrical, Chemical Engineering, or a related field is required.
  • A minimum of 3 years of experience in process and equipment automation.
  • At least 3 years of relevant experience in the pharmaceutical or biotech sectors.
  • Familiarity with automation platforms such as Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC, and/or Johnson Controls.
  • Experience with the installation and support of PI historian systems.
  • Background in Automation, Electrical Engineering, or Mechanical Engineering.
  • Knowledge of standard bioprocessing techniques and laboratory equipment.
  • Willingness to work in a clean room environment and adhere to gowning and safety protocols.