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Automation Engineer with Sterile Clinical Manufacturing Exp.

  • Full Time, onsite
  • Combined Computer Resources
  • On Site, United States of America
Salary undisclosed

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1

The automation engineer will be responsible for the following:

  1. Proficient in reading and writing ladder logic programs for automation systems, with specific expertise in installing and utilizing PLC & HMI applications from Allen-Bradley/Rockwell, Siemens, and/or Inductive Automation. This includes familiarity with RSLogix, FactoryTalk ME/SE, RSLinx, TIA Portal, WinCC OA, and/or Ignition.
  2. Skilled in programming in Python or similar languages.
  3. Knowledgeable in configuring OPC applications such as Kepware server for interconnecting automation systems.
  4. Well-versed in networking systems, TCP/IP addressing, and network ports.
  5. Familiar with Windows server setup and maintenance as well as VMware systems.

2

The automation engineer's responsibilities, aligned with clients procedures, include:

  1. Preparing and updating equipment and automation change control documentation for approval.
  2. Documenting all changes made to equipment and automation documentation and software.
  3. Preparing computer system qualification testing protocols associated with the changes for clients approval and being able to execute automation/computer system testing protocols.
  4. Ensuring compliance with all specifications during the execution of testing and documenting/reporting discrepancies to.
  5. Troubleshooting and remediating all testing discrepancies and equipment malfunctions.
  6. Documenting all automation operational and maintenance activities.

3

The automation engineer will:

  1. Provide support for the FLEx Sterile project, aiding in Automation Qualification and facility startup for the facility's Automation systems.
  2. Assist in preparing operational readiness by implementing system administration processes and developing procedures.
  3. Support pilot plant process automation project activities to ensure compliance with GMPs and EHS regulations.
  4. Review and investigate equipment and automation-related processes/issues and recommend/implement steps to remediate any identified issues.
  5. Document all network configuration setups for the interconnected pilot plant systems, including updating and/or creating network architectural drawings as necessary.

4

Develop annual Periodic Review Reports (PRR) for automation systems, which includes:

  1. Reviewing all SDLC documentation of automation systems to ensure compliance with clients requirements.
  2. Conducting a system administration review of the automation systems to oversee system user access, including a thorough review of all user accounts with the relevant business areas.
  3. Verifying all automation and code backups for PLCs, HMI, Python, etc.
  4. Reviewing all incidents, conducting root cause analysis, and providing a path forward.
  5. Ensuring the installation of all appropriate Microsoft patches via change requests.
  6. Utilizing the clients document management system for the storage and approval of the PRR documentation.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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