Senior Manager Manufacturing Systems – Drug Substance Automation

Senior Manager Manufacturing Systems – Drug Substance Automation

Requirements

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

Responsibilities

• Lead a team of automation professionals and serve as the main point of contact for automation function for Drug Substance Supply manufacturing.
• Define, drive, and deliver the automation and process control strategies within Drug substance manufacturing.
• Serve as an experienced advisor to senior level management and ensure the automation solutions & strategy development aligns with Manufacturing Process requirements.
• Strategic and tactical management and leadership in providing 24×7 day-to-day operational support and capital project support.
• Develop the scope and life cycle upgrade plan in partnership with OEM, Manufacturing & Amgen Operations Digital Transformation and Innovation (DTI) teams.
• Work with diverse groups (Manufacturing, Quality, Process Development, DTI, Safety, Global Engineering) and drive new business processes to ensure continuous and sustained automation improvement initiatives.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the automation systems.
• Ensure the safety of all personnel during plant operations, maintenance, and project implementation activities.
• Develop expense budget forecasts and adhere to the budgeted expenses.
• Responsible for Staff Management for on-site work and rotational automation on-call support planning and execution.
• Prepare and communicate plant automation highlights and lowlights on a weekly basis to the key collaborators.
• Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Responsible for ensuring that the operational functionalities for each process unit operation, cleaning & sterilization systems are configured accurately in the automation systems in line with Process Transfer Documents.
• Develop, maintain and implement preventive maintenance activities with the team for all automation assets supporting Drug Substance Supply operations.
• Responsible for periodically assessing and ensuring sufficient spare parts for the Drug Substance Manufacturing & utilities automation systems are maintained within the Central Inventory.
• 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 Electronic Reporting functionality is incorporated for all Drug Substance unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.
• Responsible for ensuring service contracts with all OEMs & Integrated Service Providers are established for automation engineering service and support needs.
• Responsible for designing, developing, deploying, maintaining, and performing backup & restoration of manufacturing process control systems, automation, and field instrumentation technologies.
• Responsible for Automation design, experience in process control engineering, and trouble shooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software.
• Responsible for leading continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., Cycle times, reduced plant utilities usage, etc.) related to Drug Substance Plant Operations.
• Lead/support technical root cause analysis, incident investigations, and trouble shooting process control issues related to plant operations.
• Responsible for ensuring that all the direct reports are adequately trained and follow all GMP standards and procedures by managing the team’s internal and external training needs.
• Responsible for ensuring the automation team actively participates in daily/weekly multi-functional work center team meetings.
• Responsible for assessing manufacturing needs and developing plans for automation system expansion to support increased plant run rate.
• Mentor the staff for their career development.

Preferred Qualifications

• Degree in Chemical Engineering or Electrical Engineering.
• 10+ years of relevant work experience in Life Science Manufacturing with a major focus on process control and automation systems.
• Emerson DeltaV Batch Distributed Control System (ISA Standard S88)
• Rockwell Automation SCADA and PLC Platform.
• Electronic Batch Reporting Systems Design and implementation
• Process Control Network design including network segregation (ISA Standard S95)
• Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced troubleshooting activities
• System Integration using Ethernet IP, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Compliance and regulatory requirements such as 21 CFR Part 11
• 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.
• Experienced in leading plant support team focused on troubleshooting, on-time support, plant maintenance, system lifecycle management, Spare Parts management, and Service level agreements.
• Experienced in New Product Introduction to engineer automation systems to meet the process requirements.
• Experienced in talent management (recruit, train, retain and performance management)
• Experienced in managing internal and external communication with key stakeholders.
• Experienced in execution excellence to ensure Right the First Time (RFT) delivery of automation engineering services to the plant operations.