BioSpace, Inc.
Senior Manager Automation Engineering (Manufacturing Systems and Utilities)
BioSpace, Inc., Holly Springs, North Carolina, United States, 27540
Overview
Senior Manager Automation Engineering (Manufacturing Systems and Utilities) at Amgen North Carolina (ANC). What You Will Do
Provide technical and administrative leadership to a group of Automation Engineers accountable for administering and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina. Meet key performance metrics, lead and technically develop reports, and ensure all targets and turning points are completed on time. Ensure the automation team applies the Corporate Automation Business Processes and drivers to deliver automation services to the organization. Lead a team of Automation Engineers and serve as the main point of contact for the automation function for ANC manufacturing. Define, drive, and deliver the automation and process control strategy within Drug Substance manufacturing. Advise senior management on automation development strategy and align with Amgen Process Development strategy. Provide 24x7 day-to-day operational support and capital project support, mentoring, staff development, team productivity, and efficient use of resources. Develop support structures with internal/multi-functional teams for capital projects, plant support, and network initiatives. Contribute to department objectives and set strategic direction within the Drug Substance Network for the F&E automation team. Maintain and improve automation systems reliability in partnership with F&E and plant leadership, focusing on maintenance excellence and recurrence avoidance. Develop scope and lifecycle upgrade plans in partnership with OEM, Manufacturing, DTI, and GLAM DTI Lead. Collaborate with Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering and drive new business processes to ensure continuous improvements; translate business needs into engineering solutions. Identify improvement opportunities, conduct analysis, sponsor and implement improvement projects. Ensure site readiness and compliance for internal and external audits; ensure safety during operations and engineering activities. Develop expense budget forecast and manage departmental budgets and capital expenses with accountability. Maintain compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits. Manage on-site and remote staff through automation on-call support planning and execution. Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%. Review unit operations, cleaning and sterilization systems to ensure correct configurations per user requirements for robustness. Oversee preventive maintenance schedules for all automation assets. Manage spare parts inventory assessment, Maximo asset allocation, and related spare parts for all manufacturing systems, including plant central utilities. Capture 100% quality compliance for RFT delivery of automation solutions and ensure reporting for production batch records, cleaning, and sterilization with audit trail and version control. Establish service contracts with OEMs for systems, including service banked hours for specialized support needs. Ensure automation staff are trained and follow GMP standards and procedures; manage internal and external training needs. Ensure the automation team can provide 24x7 reliable plant automation support across systems and facilities. Participate in daily/weekly Work Center Team meetings with Manufacturing, plant WCTs, Automation WCT, and Automation leadership WCT to address topics and resolve issues with multi-functional teams. Support expense, department capital, construction, and GLAM-DTI project implementations. Provide proactive feedback to automation staff and foster 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 experience; OR Associate degree and 10 years of Engineering experience; OR Bachelors degree and 8 years of Engineering experience; OR Masters degree and 6 years of Engineering experience; OR Doctorate degree and 2 years of Engineering experience 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 of resources. Preferred Qualifications
10+ years of relevant work experience in Life Science with a major focus on Process control and automation systems. What You Can Expect Of Us
We support your professional and personal growth and well-being with competitive benefits and a collaborative culture. Total Rewards plans are competitive and aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.
careers.amgen.com As an organization dedicated to improving quality of life, Amgen fosters an inclusive environment of diverse, ethical, committed and accomplished people who respect each other and live the Amgen values to advance science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We will provide reasonable accommodation for applicants with disabilities to participate in the job application or interview process. Please contact us to request accommodation. Seniority level
Director Employment type
Full-time Job function
Engineering and Information Technology Industries
Biotech / Pharmaceutical Referrals increase your chances of interviewing at BioSpace. Sign in to set job alerts for Senior Manager System Engineering roles. #J-18808-Ljbffr
Senior Manager Automation Engineering (Manufacturing Systems and Utilities) at Amgen North Carolina (ANC). What You Will Do
Provide technical and administrative leadership to a group of Automation Engineers accountable for administering and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina. Meet key performance metrics, lead and technically develop reports, and ensure all targets and turning points are completed on time. Ensure the automation team applies the Corporate Automation Business Processes and drivers to deliver automation services to the organization. Lead a team of Automation Engineers and serve as the main point of contact for the automation function for ANC manufacturing. Define, drive, and deliver the automation and process control strategy within Drug Substance manufacturing. Advise senior management on automation development strategy and align with Amgen Process Development strategy. Provide 24x7 day-to-day operational support and capital project support, mentoring, staff development, team productivity, and efficient use of resources. Develop support structures with internal/multi-functional teams for capital projects, plant support, and network initiatives. Contribute to department objectives and set strategic direction within the Drug Substance Network for the F&E automation team. Maintain and improve automation systems reliability in partnership with F&E and plant leadership, focusing on maintenance excellence and recurrence avoidance. Develop scope and lifecycle upgrade plans in partnership with OEM, Manufacturing, DTI, and GLAM DTI Lead. Collaborate with Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering and drive new business processes to ensure continuous improvements; translate business needs into engineering solutions. Identify improvement opportunities, conduct analysis, sponsor and implement improvement projects. Ensure site readiness and compliance for internal and external audits; ensure safety during operations and engineering activities. Develop expense budget forecast and manage departmental budgets and capital expenses with accountability. Maintain compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits. Manage on-site and remote staff through automation on-call support planning and execution. Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%. Review unit operations, cleaning and sterilization systems to ensure correct configurations per user requirements for robustness. Oversee preventive maintenance schedules for all automation assets. Manage spare parts inventory assessment, Maximo asset allocation, and related spare parts for all manufacturing systems, including plant central utilities. Capture 100% quality compliance for RFT delivery of automation solutions and ensure reporting for production batch records, cleaning, and sterilization with audit trail and version control. Establish service contracts with OEMs for systems, including service banked hours for specialized support needs. Ensure automation staff are trained and follow GMP standards and procedures; manage internal and external training needs. Ensure the automation team can provide 24x7 reliable plant automation support across systems and facilities. Participate in daily/weekly Work Center Team meetings with Manufacturing, plant WCTs, Automation WCT, and Automation leadership WCT to address topics and resolve issues with multi-functional teams. Support expense, department capital, construction, and GLAM-DTI project implementations. Provide proactive feedback to automation staff and foster 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 experience; OR Associate degree and 10 years of Engineering experience; OR Bachelors degree and 8 years of Engineering experience; OR Masters degree and 6 years of Engineering experience; OR Doctorate degree and 2 years of Engineering experience 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 of resources. Preferred Qualifications
10+ years of relevant work experience in Life Science with a major focus on Process control and automation systems. What You Can Expect Of Us
We support your professional and personal growth and well-being with competitive benefits and a collaborative culture. Total Rewards plans are competitive and aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.
careers.amgen.com As an organization dedicated to improving quality of life, Amgen fosters an inclusive environment of diverse, ethical, committed and accomplished people who respect each other and live the Amgen values to advance science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We will provide reasonable accommodation for applicants with disabilities to participate in the job application or interview process. Please contact us to request accommodation. Seniority level
Director Employment type
Full-time Job function
Engineering and Information Technology Industries
Biotech / Pharmaceutical Referrals increase your chances of interviewing at BioSpace. Sign in to set job alerts for Senior Manager System Engineering roles. #J-18808-Ljbffr