Senior Manager Manufacturing Systems Engineering ​- Automation

Amgen • Holly Springs, NC

4d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a global biotechnology company with a mission to serve patients living with serious illnesses. The Senior Manager, Manufacturing Systems Engineering - Automation will be part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility. This facility will combine disposable technologies with traditional equipment and integrate industry 4.0 capabilities and sustainability innovations. The role is within the Facilities & Engineering (F&E) group and reports to the Director of Engineering at Amgen North Carolina.

Requirements

• 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
• A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• 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

Nice To Haves

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field

Responsibilities

• Providing technical and administrative leadership to a group of Automation Engineers responsible for administering and maintaining automation systems for Drug Substance manufacturing.
• Meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time.
• Ensuring the automation team applies Corporate Automation Business Processes and drivers to deliver automation services.
• Leading a team of Automation Engineers and serving as the main point of contact for the automation function for ANC 1 manufacturing.
• Defining, driving, and delivering the automation and process control strategy within Drug substance manufacturing.
• Serving as an experienced advisor to senior level management and ensuring the automation development strategy aligns with Amgen Process Development strategy.
• Providing 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.
• Developing support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.
• Providing input into department objectives and establishing strategic direction within the Drug Substance Network for the F&E automation team.
• Maintaining and improving 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.
• Working with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) and driving new business processes to ensure continuous and sustained improvements.
• Translating business needs into engineering technology solutions.
• Leading analysis of alternatives and recommendations for technical/business proposals.
• Identifying areas of potential improvement, conducting analysis, recommending solutions, sponsoring improvement projects, and implementing.
• Ensuring site readiness and compliance for internal audits, external agency audits, and partner audits.
• Ensuring the safety of all personnel during plant operations and engineering activities.
• Developing expense budget forecast and adhering to department budgets and spend for operational and capital expenses, holding 100% accountability.
• Being knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and supporting regulatory inspections and audits.
• Ensuring Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Ensuring the right processes/systems are in place to capture 100% quality compliance for the right-first-time (RFT) delivery of automation solutions.
• Ensuring that reporting functionality is incorporated for all unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.
• Ensuring that service contracts with all OEMs for systems are established for service and support needs, including service banked hours for specialized support needs.
• Ensuring that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.
• Ensuring 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.
• Ensuring that the automation team actively participates in daily/weekly Work Center Team (WCT) meetings to address day-to-day topics and discuss issues with multi-functional teams to resolve.
• Ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.
• Providing active leadership such that proactive feedback is solicited from the automation staff and actions are taken to maintain proper work-life balance.

Benefits

• 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-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior