Senior Sterilization Engineer [Remote]

Career Category

Engineering

Job Description

Join 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.

Senior Sterilization Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will work as part of a multi-disciplinary program to build and maintain drug delivery solutions which meet user requirements for Amgen’s portfolio of therapeutic products from concept through commercial production. The individual will be responsible for designing, conducting, and analyzing new process development, validation and requalification studies for gas sterilization modalities for combination products at multiple sterilization processing vendor sites. This role will serve as sterilization technical lead to support commercial production sterilization processing operations for at least one vendor. The successful candidate will lead collaborations with cross-functional teams to ensure compliance with regulatory standards and industry best practices. This role will also include assessments and approvals of Amgen primary container systems supplier sterilization process validations, requalification and site transfers, as well as performing sterilization standards changes impact assessments for Amgen primary container systems.

• Sterilization Technical Lead for commercial launch and production sterilization processing operations for a novel gas sterilization process for a combination product
• Lead/ support sterilization process deviations impact assessments for routine production
• Lead/ support sterilization process annual reviews and requalifications; bioburden and environmental monitoring activities and Biological Indicator (BI) test report reviews
• Support audit preparation, inspection readiness and onsite audit activities
• Support/ lead process development of gas sterilization processes of combination products
• Coordinate manufacturing site requirements to support sterilization requirements
• Support tech transfer projects for combination products sterilization processes
• Support on-going deviation/ CAPA and change control
• Support/ lead Amgen primary container system supplier sterility assurance assessments for gamma, E-beam, X-Ray, ethylene oxide and steam sterilization modalities; and microbiological evaluations
• Collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
• Drive and influence key opinion leaders by providing technical papers, presentations and attending conferences
• Lead sterilization standards changes impact assessments for Amgen primary container systems
• Lead/ support authorship of regulatory filings and responses to regulatory agency questions
• Provide sterilization training to key internal and external stakeholders

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience; OR
• Associate’s degree and 8 years of Engineering experience; Or
• Bachelor’s degree and 4 years of Engineering experience; Or
• Master’s degree and 2 years of Engineering experience; Or
• Doctorate degree

Preferred Qualifications:

• 3+ years of experience in biotechnology/pharmaceutical industry
• 3+ years of experience in primary container, medical devices, etc.
• 3+ years of experience in testing, equipment, method, and mechanical design
• 1+ years industry experience in sterility assurance of combination products
• 2+ years in ethylene oxide, vaporized hydrogen dioxide or other gas sterilization modalities
• 1+ years in gas sterilization process development, validation and routine production
• 1+ years in radiation sterilization
• 1+ years in bioburden/ environmental monitoring analysis
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Capability to advance multiple projects in a fast paced environment
• Project management experience/ Multi-tasker to enable managing multiple deliverables/priorities
• Flexible/Highly adaptive to continuous changing priorities/environment
• Strong teammate, interpersonal and communication skills
• Strong oral and written communication skills, including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
• Strong technical writing skills Experience with regulatory filings/ responses authoring/ support
• ISO 14937, ISO 11135, ISO 11137, ISO 11138, ISO 10993, ISO 11737
• Fast and continuous learner
• Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes

What you can expect from 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.

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.

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 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
• 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.

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In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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. 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.

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Salary Range

119,195.00 USD - 147,867.00 USD