Senior Manager Manufacturing Systems Engineering?- Automation

Senior Manager Manufacturing Systems Engineering - Automation

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

What You Will Do

Let's do this. Let's change the world. In this role The Senior Manager is responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for administrating and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization.

As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering at Amgen North Carolina. This role is expected to provide leadership as follows:

• Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC 1 manufacturing. Systems including Allen Bradley PLCs, Siemens Desigo CC for building automation, and Emerson DeltaV for process control.
• Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing.
• Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.
• Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources.
• Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.
• Provide input into department objectives and establishing strategic direction within the Drug Substance Network for the F&E automation team.
• Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on "Maintenance Excellence" systems failures and recurrence avoidance.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
• Identify areas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits.
• Ensure the safety of all personnel during plant operations and engineering activities.
• Develop expense budget forecast and adhere to department budgets and spend for operational and capital expenses, holding 100% accountability.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time (RFT) delivery of automation solutions.
• Ensure that reporting functionality is incorporated for all unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.
• Responsible for ensuring that service contracts with all OEMs for systems are established for service and support needs, including service banked hours for specialized support needs.
• Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.
• Ensure the automation staff are fully aware and confident to work on all automation systems, process equipment, and facility to provide 24x7 reliable plant automation support.
• Responsible for ensuring that the automation team actively participates in daily/weekly Work Center Team (WCT) meetings Manufacturing area & plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.
• Responsible for ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.
• Provide active leadership such that proactive feedback is solicited from the automation staff and actions are taken to maintain proper work-life balance.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The engineering management professional we seek will possess these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Engineering and/or Project Management experience OR
• Associate's degree and 10 years of Engineering and/or Project Management experience OR
• Bachelor's degree and 8 years of Engineering and/or Project Management experience OR
• Master's degree and 6 years of Engineering and/or Project Management experience OR
• Doctorate degree and 2 years of Engineering and/or Project Management experience

Additionally: 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, Biotech Engineering, or related field
• Experience with Emerson DeltaV DCS system, Siemens Desigo CC, Allen Bradley PLC and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
• Direct knowledge of automation system design
• Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
• Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
• Experience in integrating various OEM automation software
• Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
• Fieldbus, and Profibus 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
• Self-directed team player able to work cross-functionally
• Strong leadership, technical writing, and communication skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales