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Senior Process Controls Engineer

Manus Bio

Why work at Manus Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement. Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations. Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on the cutting edge. Responsibilities Technical Leadership & Advanced Engineering Serve as site SME for process control systems, including PLC, DCS, HMI, SCADA, and associated instrumentation; provide authoritative guidance to engineering and operations teams. Lead the design, configuration, testing, and commissioning of complex control systems for new and modified processes, ensuring integration with upstream and downstream operations. Evaluate and select control hardware and software platforms; develop and enforce site-wide standards for control architecture, programming conventions, and documentation. Lead advanced troubleshooting of process control issues; perform root cause analysis (RCA) and drive implementation of permanent corrective and preventive actions (CAPA). Project Management & Capital Support Own and lead area capital projects from scope development and cost justification through control logic design, factory acceptance testing (FAT), and site commissioning. Develop project plans, manage timelines, coordinate contractor and vendor activities, and communicate project status to engineering and site leadership. Review and approve engineering deliverables including P&IDs, control narratives, cause-and-effect matrices, functional specifications, and as-built documentation. Mentor and guide Process Controls Engineer I/II staff on project execution and technical best practices. Production Support & Continuous Improvement Provide senior-level technical support to Production for control system configuration, process control parameter changes, and process troubleshooting across multiple systems. Partner with Production and Process Development to identify and implement improvements in automation, efficiency, data collection, and reporting. Champion and lead continuous improvement initiatives that reduce downtime, improve process reliability, and increase overall equipment effectiveness (OEE). Analyze process and historian data to identify control performance gaps and recommend enhancements to control strategies. Training, Documentation & Compliance Develop, maintain, and deliver training programs for console operators on automated systems, including training materials and process simulation tools. Ensure all control system work and documentation adheres to site GMP guidelines, change control procedures, and applicable regulatory standards. Support site safety and quality initiatives through active participation and leadership in incident investigations, CAR analysis, and follow-up actions. Maintain accurate and complete documentation in accordance with good documentation practices (GDP) and site quality management systems. Qualifications Bachelor’s degree in Engineering (Chemical, Electrical, Mechanical, or related discipline). Minimum 5–7 years of progressive experience in process controls or automation engineering in a manufacturing environment; biotech, pharmaceutical, or specialty chemical experience strongly preferred. Demonstrated hands‑on expertise with PLC and/or DCS platforms (e.g., Rockwell, Siemens, Emerson DeltaV, Honeywell) including programming, configuration, and commissioning. Proven experience leading capital projects, including scope development, cost estimation, and site commissioning. Strong knowledge of process instrumentation (flow, pressure, temperature, level, analytical) and control loop tuning. Solid understanding of safety, health, environmental, quality systems, and GMP regulatory compliance requirements. Excellent verbal and written communication skills with the ability to present technical content to both technical and non‑technical audiences. Strong analytical and problem‑solving skills; demonstrated ability to lead RCA investigations and implement lasting solutions. Physical ability to perform equipment inspection and troubleshooting in a manufacturing environment, including climbing stairs and ladders and wearing required PPE. Work schedule flexibility during shutdowns and other extraordinary operational conditions. Preferred Qualifications Experience with bioprocess automation, fermentation systems, or BioFacility environments. Proficiency with SCADA systems, historian platforms (e.g., OSIsoft PI), and MES integration. Familiarity with ISA‑88 batch control standards and ISA‑99/IEC 62443 cybersecurity standards for industrial control systems. Knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures in a GMP setting. Experience with process simulation tools and operator training systems (OTS). Professional Engineer (PE) license or pursuit thereof. Prior experience mentoring or leading junior engineering staff. Core Competencies Controls and Automation expertise Project Leadership Analytical thinking & RCA Cross‑functional collaboration GMP & Regulatory acumen Mentorship & knowledge sharing Continuous improvement mindset Clear technical communication #J-18808-Ljbffr

Vacancy posted 3 days ago
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