Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream

What you will do

Let’s do this! Let’s change the world! In this vital role, you will oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs. You will solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

The Senior Manager Manufacturing System Engineering will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director. This role will partner closely with the corporate engineering team during the design, build, commissioning, and qualification phases. This role will be instrumental in developing automation domain expertise and supporting operational readiness and will develop domain expertise to support operations upon start-up, focusing on manufacturing automation as well as hiring and training the staff required to support startup and operations.

Job responsibilities include:

Site design, 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 DeltaV 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.

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Site Operations:

• Lead a team of Automation engineer professionals and serve as the main point of contact for 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 day-to-day 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.

• Up to 10% domestic/international travel

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What we expect of you

• High school diploma / GED and 12 years of engineering experience OR

• Associate’s degree and 10 years of engineering experience OR

• Bachelor’s degree and 8 years of engineering experience OR

• Master’s degree and 6 years of engineering experience OR

• Doctorate degree and 2 years of engineering experience

And

• 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

Preferred Qualifications:

• Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering.

• Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.

• Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.

• Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing.

• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.

• In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation

• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.

• Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.

• Ability and willingness 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.

• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage