Senior Manager

1 month ago

Albany, New York, United States Amgen Full time

HOW 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

Live

What 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.
  • Ensuring 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
  • Coordinated project management activities for validation projects are 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

Win

What 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

Or

Master's degree and 4 years of directly related experience

Or

Bachelor's degree and 6 years of directly related experience

Or

Associate's degree and 10 years of directly related experience

Or

High 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 or 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.

Thrive

What 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 now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen 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.


  • Senior Care Professional with Senior Helpers

    2 days ago

    Albany, New York, United States Senior Helpers - New Albany Full time

    About Senior Helpers - New AlbanySenior Helpers - New Albany is a leading provider of in-home senior services, dedicated to helping seniors age with dignity despite age-related illnesses and mobility challenges. Our mission is to deliver high-quality care and support to seniors in the comfort of their own homes.Job SummaryWe are seeking a compassionate and...

  • Senior Financial Manager

    3 days ago

    Albany, New York, United States Jobot Full time

    About the RoleWe are seeking a highly skilled Senior Accountant to join our team at Jobot. As a key member of our finance department, you will be responsible for overseeing and managing all general ledger activity, ensuring accuracy and timeliness in financial reporting.Key ResponsibilitiesFinancial Reporting: Prepare and analyze monthly financial...

  • Senior Financial Operations Manager

    5 days ago

    Albany, New York, United States CAPITAL CFO+ LLC Full time

    Job DescriptionCompany: CAPITAL CFO+ LLCPosition: Senior Financial Operations ManagerOverview:The Senior Financial Operations Manager will oversee the financial and accounting functions within CAPITAL CFO+ LLC. This role is essential for ensuring the accuracy and integrity of financial reporting and compliance with applicable regulations. The ideal candidate...

  • Senior Manager

    1 month ago

    Albany, New York, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products...

  • Business Operations Manager

    2 days ago

    Albany, New York, United States North Albany Senior High School Full time

    About the RoleWe are seeking a highly organized and proactive Corporate Services Manager to join our team at North Albany Senior High School. As a key member of our leadership team, you will work closely with the Principal to manage the strategic and day-to-day financial, physical, and human resources aspects of our school's business operations.Key...

  • Senior Audit and Accounting Manager

    5 days ago

    Albany, New York, United States Abacus Group Full time

    Abacus Group is looking for a proficient Senior Audit and Accounting Manager to enhance our dynamic team.Key Responsibilities Manage all facets of standard and intricate audit and review assignments. Direct the engagement team while offering constructive insights to junior staff. Effectively coordinate client internal controls and accounting frameworks....

  • Senior Project Manager

    8 hours ago

    Albany, New York, United States The LiRo Group Full time

    About the RoleWe are seeking a highly experienced Senior Project Manager to lead our construction management team in Albany, NY. As a key member of our team, you will be responsible for coordinating construction efforts on multiple projects, ensuring timely completion of project work, and managing a team of at least 8 employees.Key ResponsibilitiesCoordinate...

  • Senior Project Manager

    1 week ago

    Albany, New York, United States Avenues International Full time

    Job OverviewGreetings,I am David representing Avenues International Inc, a reputable IT Staffing & Consulting firm established in 1994, serving clients across the United States. We proudly hold a prime vendor status with the New York State, focusing on their Hourly-Based IT Services (HBITS) requirements.We currently have an immediate opening for a Senior...

  • Senior Civil Engineering Manager

    2 weeks ago

    Albany, New York, United States gpac Full time

    Job OverviewWe are currently seeking aSenior Civil Engineering Managerto join our dynamic team. This senior-level role involves overseeing management and design responsibilities for various stages of land development, civil engineering, and utility projects.Key Benefits:- Annual performance bonus- Generous paid time off- Excellent work-life balance-...

  • Senior Manager, Electric Vehicle Initiatives

    1 week ago

    Albany, New York, United States Fusco Personnel, Inc. Full time

    Position OverviewSenior Manager, Electric Vehicle InitiativesFusco Personnel, Inc. is seeking a qualified candidate to take on the role of Senior Manager, Electric Vehicle Initiatives. This position is pivotal in advancing efforts to combat climate change and facilitate the transition towards a sustainable energy economy. The role offers a competitive salary...

  • Industrial Construction Project Manager

    2 days ago

    Albany, New York, United States Jobot Full time

    Job OverviewWe are a reputable General Contractor in the Northeast, specializing in multiple sectors within the construction industry. With over 100+ years of experience, we thrive on bringing innovative solutions in a competitive market.Job SummaryWe are seeking a highly motivated and experienced Senior Project Manager to join our team in the area of...

  • Senior Structural Engineering Manager

    3 hours ago

    Albany, New York, United States GAI Consultants Full time

    About This Position:We are seeking an experienced Senior Engineering Manager to join our consulting firm in Albany and Westchester, New York.Key Responsibilities:Prepare or check calculations and/or direct the design procedures of others to ensure that calculations are in accordance with AASHTO and NYSDOT design standards.Prepare Design Reports,...

  • Senior Manager of Audit and Accounting

    4 hours ago

    Albany, New York, United States Abacus Group Full time

    About the RoleAbacus Group is seeking a highly skilled Audit and Accounting Senior Manager to join our team. As a key member of our accounting department, you will be responsible for leading complex audit and review engagements, managing client relationships, and providing expert guidance on accounting matters.Key ResponsibilitiesManage all aspects of...

  • Senior Manager, Program Management Lead

    3 days ago

    Albany, New York, United States AmplifyBio Full time

    About the RoleWe are seeking an experienced and dynamic Program Management Group Lead to join our Technical Operations team at AmplifyBio.The successful candidate will oversee a team of project managers and drive the successful execution of multiple client programs across our advanced therapy portfolio.Key ResponsibilitiesLead, recruit, train, and develop...

  • Senior Utilization Manager

    1 week ago

    Albany, New York, United States TenderHeart Health Outcomes Full time

    Job OverviewTenderheart Health Outcomes stands as the premier provider of Incontinence Management Services across the nation. Our mission is to deliver high-quality products and services that empower individuals to manage their incontinence effectively at home, while simultaneously generating healthcare savings within various managed care sectors.Through our...

  • Senior Energy and Sustainability Manager

    5 days ago

    Albany, New York, United States JLL Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Energy and Sustainability Manager to join our team at JLL. As a key member of our Sustainability and Energy team, you will play a critical role in driving our company's sustainability goals and objectives.Key ResponsibilitiesDevelop and implement energy and sustainability programs for our...

  • Senior Structural Engineer

    2 days ago

    Albany, New York, United States Stantec Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Structural Engineer to join our team at Stantec. As a Senior Structural Engineer, you will be responsible for leading cross-functional teams and managing projects of significant scope and complexity. You will apply your expertise in buildings structural engineering principles and client...

  • Senior Equipment Operations Manager

    2 weeks ago

    Albany, New York, United States The United Group of Companies, Inc. Full time

    Celebrating over 50 years in the industry, our company excels in various aspects of real estate including development, financing, construction, and property management. As a distinguished organization, we provide top-notch products and exceptional resident experiences across diverse sectors such as active adult senior living, student housing, multi-family...

  • Senior B2B Partnership Manager

    2 weeks ago

    Albany, New York, United States B&H Pro Audio Video Full time

    The Senior B2B Partnership Manager plays a crucial role in cultivating and enhancing relationships with significant B&H business associates and clients to drive business expansion. This position primarily targets clients in the governmental, educational, and corporate sectors, with a special emphasis on purchasing cooperatives, GPOs, and select major...

  • Senior Financial Operations Manager

    5 days ago

    Albany, New York, United States CAPITAL CFO+ LLC Full time

    Job OverviewBenefits:401(k)Dental insuranceHealth insurancePaid time offAbout CAPITAL CFO+ LLC:Dedicated to Excellence in Financial ServicesPosition Summary:The Finance Manager at CAPITAL CFO+ LLC is tasked with overseeing the comprehensive financial and accounting functions of the organization. This role is crucial for maintaining the financial health of...