Senior Manufacturing Systems Engineer: Automation

Senior Manufacturing Systems Engineer: Automation

Requirements

• High School Diploma / GED and 10 years of Engineering experience OR
• Associate’s Degree and 8 years of Engineering experience OR
• Bachelor’s Degree and 4 years of Engineering experience OR
• Master’s Degree and 2 years of Engineering experience OR
• Doctorate Degree

Responsibilities

• Provide automation technical leadership to a group of automation engineers responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
• Develop and maintain the building automation system on Siemens Desigo CC.
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how utility and building equipment systems automation can improve workflow and productivity.
• Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Build the business processes to support the project scope in alignment with project timelines.
• Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation controls.
• Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
• Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Utility systems, Utility and BAS Administration, Preventative and corrective maintenance, and Automation System spare parts management.
• Be constantly curious and feed your passion and interests in groundbreaking technology.

Preferred Qualifications

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
• Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.
• Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies.
• Experience with Siemens Building Automation system, Rockwell industrial automation hardware and systems, ability to perform advanced troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.).
• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.