Automation Systems Engineer

We are seeking a highly skilled Automation Engineer to drive improvements in our pharmaceutical manufacturing processes. In this role, you will leverage your expertise in PLC, HMI, and SCADA systems to optimize equipment performance and ensure regulatory compliance. Your contributions will be critical to the successful operation of our biotherapeutic manufacturing area., * Serve as a Subject Matter Expert (SME) for automation systems, providing guidance on troubleshooting and implementing efficiency improvements.

• Lead the development and execution of automation projects, ensuring alignment with project goals and timelines.
• Author and maintain quality documentation, including SOPs, change controls, and validation protocols.
• Conduct risk assessments and gap analyses for equipment, processes, and facility tech transfers.
• Collaborate with cross-functional teams to develop system requirements and recommendations for modifications.
• Participate in Factory Acceptance Testing (FAT), commissioning, and validation activities (IQ/OQ/PQ).
• Manage project risks, budgets, and schedules, reporting progress to management as needed.
• Ensure equipment and utility systems are GMP compliant and reliably performing to validated function.

• Bachelor’s degree in engineering or a related field.
• Minimum 3 years of experience in a Pharmaceutical/Biotech environment.
• Strong working knowledge of PLC’s, HMI’s, and SCADA systems.
• Experience with aseptic manufacturing and fermentation processes., * EIT/PE License.
• Lean/Six Sigma certification.
• PMP certification.
• Proficiency in MS Project, Excel, Word, and PowerPoint.