Controls Engineer

Travel: Yes, 25 % of the Time


We are hiring a Senior Controls Engineer who is responsible for the control systems on the manufacturing and packaging equipment in the Pharmaceutical/Manufacturing Industry.

Job duties:

  • SME for PLC, HMI, and Robot software updates and programming.
  • SME for audit trails, batch trails, and data integrity on commercial equipment.
  • Responsible for creating new Robot recipes for packaging new product.
  • Maintain database of software backups on all commercial equipment.
  • Assist with network and LDAP authentication within the manufacturing IT network.
  • Draft User Requirement Specifications (URS) for manufacturing and packaging equipment.
  • Organizes and generates all relevant controls data to prepare project scopes, cost estimates, economic justifications, and capital appropriation requests, as required, to obtain management approval. Manage and maintain project budgets; ensure project execution per planned budgets.
  • Create and update GMP documentation as needed by the project, including, but not limited to, equipment qualifications, change controls, SOP’s, equipment manuals.
  • Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems.
  • Engage with both internal personnel and external vendors for issue resolution.
  • Supports site reliability efforts by monitoring key equipment performance variables and proactively identifying and addressing issues before they cause unplanned equipment downtime.
  • Initiate and own change controls for equipment modifications.
  • Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
  • Routinely interact with internal Technical Services, QA, and EH&S personnel to achieve project and production goals.
  • Lead for the execution of start-up and commissioning activities for minor and major equipment upgrades.
  • Contributing to equipment safety reviews.
  • Champion the use of continuous improvement.
  • Mentors and trains other engineers on automation practices.
  • Domestic and International travel required.
  • Perform other Tasks as assigned.

Required qualifications:

  • Bachelor’s degree in Engineering or related field.
  • 6 or more years (6+) of relevant work experience in a pharmaceutical or similar manufacturing engineering environment
  • Experience with the procurement, installation, and validation of complex equipment
  • Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements
  • Strong written and oral communication skills, technical writing experience
  • Excellent interpersonal skills, with the ability to work independently and prioritize critical tasks
  • Proficient in Microsoft Office, and some or all of: CAD software, ladder logic programming, Rockwell Automation software/hardware, Siemens software/hardware, Fanuc Robots, Universal Robots, and ABB Robots.

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