Automation Engineer

Our pharmaceutical manufacturing client in Raleigh, NC is looking for an Automation Engineer with strong Siemens Step7 PLC experience to support automation design, integration, and testing of GMP manufacturing equipment.

Responsibilities

• Provide design review and technical input for Siemens Step7 PLC-controlled equipment, ensuring automation requirements are clearly defined and met.
• Support integration of equipment with site systems such as DeltaV, OSI PI, BMS, and other automation or data systems as needed.
• Participate in and support Factory Acceptance Testing (FAT) at vendor locations, including protocol review, test execution support, and documentation.
• Ensure PLC-controlled equipment complies with site data integrity requirements (e.g., 21 CFR Part 11, ALCOA+); assist in the development and design of compliant solutions.
• Review and contribute to automation life cycle documentation (URS, FS, DS, risk assessments, test plans, change controls).
• Collaborate and coordinate with cross-functional teams including Automation, CSV, CQV, Utilities, and Process Engineering to ensure successful project delivery.

Qualifications

• 3–5 years of experience as an Automation Engineer, Controls Engineer, or similar role in a pharmaceutical, biotech, or other GMP / regulated manufacturing environment.
• Hands-on experience with Siemens Step7 PLC systems (programming, troubleshooting, and support).
• Experience integrating PLC systems with DeltaV, OSI PI, BMS, or comparable control/data systems.
• Understanding of GMP and data integrity requirements (e.g., 21 CFR Part 11, ALCOA+).
• Experience supporting FAT/SAT, commissioning, and/or qualification activities.
• Ability to read and interpret P&IDs, control narratives, I/O lists, and design specifications.
• Strong communication and teamwork skills, with the ability to work effectively in a multi-disciplinary project environment.

Preferred Skills

• Experience with capital projects (new equipment installations or major upgrades) in pharma/biotech.
• Familiarity with CSV/CSA practices for automated systems.
• Experience with OSI PI or other data historians and site-level automation architectures.

Work Environment

• This role is onsite at the client’s Raleigh, NC facility.
• Occasional travel to vendor sites for FAT may be required.