Amgen Inc. (IR)
Senior Manager Manufacturing Systems Engineering - AML14 Drug Product
Amgen Inc. (IR), Oregon, Illinois, United States, 61061
Senior Manager Manufacturing Systems Engineering - AML14 Drug ProductJoin 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 mission—to serve patients living with serious illnesses—drives 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will doLet’s do this. Let’s change the world! In this vital role, you will lead the development and implementation of automation initiatives across the AML14 Drug Product organization, including identifying automation opportunities, selecting appropriate tools and technologies, creating and testing automation scripts, and integrating these into existing systems. You will also oversee staff development, production schedules, and continuous improvement programs within the area.
Specific responsibilities include but are not limited to:
Anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.
Perform and lead cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solutions, managing multiple initiatives and priorities.
Translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans using business drivers to operational needs and project/process improvements requirements.
Communicate with multiple levels within the organization, highlighting issues and proposing solutions.
Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design and tangible solutions.
Assess team workload and distribute resources to meet business goals and support new product launch commitments and mentoring & educating team members on best practices in automation.
Monitor and ensure continued compliance with team training metrics.
Assist with audit inspections and guarantee that manufacturing systems are prepared for inspection.
Lead the AML 14 Global Lifecycle Asset Management roadmap to set priorities for equipment upgrades.
Adhere to schedules for Change Control Implementations and CAPA activities related to the automation framework.
Manage the control-related preventive maintenance and general maintenance tasks for AML 14 control systems.
Secure AML 14 manufacturing and process equipment servers through regular software patching in alignment with quarterly metrics and expectations.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Sr. Manager Manufacturing System Engineering professional we seek is a collaborative leader with these qualifications:
Basic Qualifications:
Doctorate degree in Engineering and 2 years of process automation manufacturing support experience
OR
Master’s degree in Engineering and 6 years of process automation manufacturing support experience
OR
Bachelor’s degree in Engineering and 8 years of process automation manufacturing support 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. Your managerial experience may run concurrently with the required technical experience referenced above.
Beyond that, additional preferred qualifications are:
Drug Product operations experience with a solid understanding of cGMP’s.
Engineering, Information Systems, Computer, and/or Software GMP-regulated industry background with experience leading projects and resources.
4+ years of experience leading resources, teams, and/or managing people.
5+ years of combined experience with Automation/ Process Control Systems (PCS), Manufacturing Execution Systems (MES), and/or laboratory systems or IS platforms.
Proficient in two or more of these software’s: Rockwell FactoryTalk, Rockwell PLCs, Simens Process Control, and/or OSIsoft PI Data Historian.
Validation and change control methodology experience with an understanding of cyber security and manufacturing network principles as applied to operations technologies.
Experience in PCS/MES implementation, validation, and change control.
Effective verbal, and written communication, and facilitation skills in Spanish & English languages.
Well organized, have a multi-task project experience, and be able to communicate and work well with other departments.
Strong written communication skills including technical writing skills, negotiation and conflict resolution.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, life and disability insurance.
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.
Flexible work models, including remote and hybrid work arrangements, where possible.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
About UsAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
#J-18808-Ljbffr
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will doLet’s do this. Let’s change the world! In this vital role, you will lead the development and implementation of automation initiatives across the AML14 Drug Product organization, including identifying automation opportunities, selecting appropriate tools and technologies, creating and testing automation scripts, and integrating these into existing systems. You will also oversee staff development, production schedules, and continuous improvement programs within the area.
Specific responsibilities include but are not limited to:
Anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.
Perform and lead cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solutions, managing multiple initiatives and priorities.
Translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans using business drivers to operational needs and project/process improvements requirements.
Communicate with multiple levels within the organization, highlighting issues and proposing solutions.
Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design and tangible solutions.
Assess team workload and distribute resources to meet business goals and support new product launch commitments and mentoring & educating team members on best practices in automation.
Monitor and ensure continued compliance with team training metrics.
Assist with audit inspections and guarantee that manufacturing systems are prepared for inspection.
Lead the AML 14 Global Lifecycle Asset Management roadmap to set priorities for equipment upgrades.
Adhere to schedules for Change Control Implementations and CAPA activities related to the automation framework.
Manage the control-related preventive maintenance and general maintenance tasks for AML 14 control systems.
Secure AML 14 manufacturing and process equipment servers through regular software patching in alignment with quarterly metrics and expectations.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Sr. Manager Manufacturing System Engineering professional we seek is a collaborative leader with these qualifications:
Basic Qualifications:
Doctorate degree in Engineering and 2 years of process automation manufacturing support experience
OR
Master’s degree in Engineering and 6 years of process automation manufacturing support experience
OR
Bachelor’s degree in Engineering and 8 years of process automation manufacturing support 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. Your managerial experience may run concurrently with the required technical experience referenced above.
Beyond that, additional preferred qualifications are:
Drug Product operations experience with a solid understanding of cGMP’s.
Engineering, Information Systems, Computer, and/or Software GMP-regulated industry background with experience leading projects and resources.
4+ years of experience leading resources, teams, and/or managing people.
5+ years of combined experience with Automation/ Process Control Systems (PCS), Manufacturing Execution Systems (MES), and/or laboratory systems or IS platforms.
Proficient in two or more of these software’s: Rockwell FactoryTalk, Rockwell PLCs, Simens Process Control, and/or OSIsoft PI Data Historian.
Validation and change control methodology experience with an understanding of cyber security and manufacturing network principles as applied to operations technologies.
Experience in PCS/MES implementation, validation, and change control.
Effective verbal, and written communication, and facilitation skills in Spanish & English languages.
Well organized, have a multi-task project experience, and be able to communicate and work well with other departments.
Strong written communication skills including technical writing skills, negotiation and conflict resolution.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, life and disability insurance.
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.
Flexible work models, including remote and hybrid work arrangements, where possible.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
About UsAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
#J-18808-Ljbffr