Amgen Inc. (IR)
Senior Manager - Validation
Amgen Inc. (IR), New Albany, Ohio, United States, 43054
Senior Manager - ValidationApply
Remote Type: On Site
Location: US - Ohio - New Albany
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: R-193182
Career CategoryEngineering
Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Manager Validation
LiveWhat you will do
Let’s do this. Let’s change the world. In this role as a leader at Amgen Ohio, you will establish and develop a team of engineers and contractors to perform validation activities for the site. You will lead and coordinate the site validation process for equipment and combination products, and establish procedures for equipment and process validation, as well as validation lifecycle management.
Manage team to lead and support site validation activities.
Ensure the initiation, preparation, and closeout of all validation-related documents and change controls.
Lead all aspects of the development of the validation plan and strategy, and manage the implementation of C&Q/Characterization and Validation. Validation Lead for all validation projects.
Coordinate business activities and assign business tasks to support activities.
Evaluate proposed changes to validated systems and recommend level of validation required.
Coordinate project management activities for validation projects within scope and budget.
Assist with the development of system requirements and specifications to ensure requirements are testable and met.
Coach and develop team in the proper assessment and execution of validation activities.
Create, review and approve validation test scripts for compliance with appropriate procedures and policies.
Site representative for government agency audits.
WinWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will have these qualifications.
Basic Qualifications:Doctorate degree and 2 years of directly related experience
OrMaster’s degree and 4 years of directly related experience
OrBachelor’s degree and 6 years of directly related experience
OrAssociate’s degree and 10 years of directly related experience
OrHigh school diploma / GED and 12 years of directly related 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.
Preferred Qualifications:
6+ years biotech or pharmaceutical industry experience.
Significant Validation experience on Pharmaceutical/Medical Device Process and Equipment Validation with focus on Combination Products.
Able to facilitate and influence senior team members and partners.
Able to successfully manage workload and timelines.
Ability to negotiate a strategic position after taking feedback from multiple sources.
Strong project management, problem-solving, and analytical skills.
Collaborates and communicates well with others, able to balance divergent inputs from various team members and drive issue resolution. Experience with presenting to regulatory agencies.
Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
ThriveWhat 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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-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.
Apply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
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Remote Type: On Site
Location: US - Ohio - New Albany
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: R-193182
Career CategoryEngineering
Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Manager Validation
LiveWhat you will do
Let’s do this. Let’s change the world. In this role as a leader at Amgen Ohio, you will establish and develop a team of engineers and contractors to perform validation activities for the site. You will lead and coordinate the site validation process for equipment and combination products, and establish procedures for equipment and process validation, as well as validation lifecycle management.
Manage team to lead and support site validation activities.
Ensure the initiation, preparation, and closeout of all validation-related documents and change controls.
Lead all aspects of the development of the validation plan and strategy, and manage the implementation of C&Q/Characterization and Validation. Validation Lead for all validation projects.
Coordinate business activities and assign business tasks to support activities.
Evaluate proposed changes to validated systems and recommend level of validation required.
Coordinate project management activities for validation projects within scope and budget.
Assist with the development of system requirements and specifications to ensure requirements are testable and met.
Coach and develop team in the proper assessment and execution of validation activities.
Create, review and approve validation test scripts for compliance with appropriate procedures and policies.
Site representative for government agency audits.
WinWhat we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will have these qualifications.
Basic Qualifications:Doctorate degree and 2 years of directly related experience
OrMaster’s degree and 4 years of directly related experience
OrBachelor’s degree and 6 years of directly related experience
OrAssociate’s degree and 10 years of directly related experience
OrHigh school diploma / GED and 12 years of directly related 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.
Preferred Qualifications:
6+ years biotech or pharmaceutical industry experience.
Significant Validation experience on Pharmaceutical/Medical Device Process and Equipment Validation with focus on Combination Products.
Able to facilitate and influence senior team members and partners.
Able to successfully manage workload and timelines.
Ability to negotiate a strategic position after taking feedback from multiple sources.
Strong project management, problem-solving, and analytical skills.
Collaborates and communicates well with others, able to balance divergent inputs from various team members and drive issue resolution. Experience with presenting to regulatory agencies.
Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
ThriveWhat 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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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-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.
Apply nowfor a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
#J-18808-Ljbffr