Senior Manager Manufacturing System Engineering- Bulk Drug Substance - Upstream

Sitedesign, construction, start-up, and operational readiness

• Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function.
• Support design reviews while partnering closely with the corporate engineering team.
• Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson Delta V Distributed Control System (DCS).
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation, and change controls.
• Provide mentoring to develop and accelerate site technical automation capabilities.

SiteOperations

• Lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function.
• Accountable for Automation System Administration, Automation System Operating Systems (OS) and HotFix assessments and rollout, preventative and corrective maintenance, Automation System spare parts management, and ownership of departmental Standard Operating Procedures (SOPs).
• Manage daily automation support including 24 x 7 onsite/on-call support, troubleshooting, and daily manufacturing and engineering meetings.
• Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
• Perform automation change assessments, implement automation system configuration changes, and support engineering and process qualification runs.
• Represent automation in cross-functional design reviews and audits.
• Look for new and innovative ways to do business differently, better, and more cost effectively.
• Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability.
• Perform and maintain data integrity in accordance with the current Amgen and industry standards.
• Provide technical support to troubleshoot, identify, and resolve process and system issues as needed.
• Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
• Participate in the budgeting process for Automation engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.

Qualifications

• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.