Senior Sterilization Engineer

HOW MIGHT YOU DEFY IMAGINATION?

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Sterilization Engineer

Live

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 the sterilization technical site lead to support commercial launch activities and production sterilization processing operations for at least one vendor. The successful candidate will lead collaborations with multi-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.

• Site 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 requalification's; 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
• Develop sterility assurance specifications of primary container closure systems for new and existing Amgen products
• Support primary container systems Container Closure Integrity (CCI) Testing and Methods Qualifications inclusive of inline new opportunities.
• 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 partners 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 partners

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 is a detail oriented professional with these qualifications.

Basic Qualifications:

• Doctorate degree of Engineering or related fields/experience

Or

• Master's degree and 2 years of Engineering or related experience

Or

• Bachelor's degree and 4 years of Engineering or related experience

Or

• Associate's degree and 8 years of Engineering or related experience

Or

• High school diploma / GED and 10 years of Engineering or related experience

Preferred Qualifications:

3 years of experience in the 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

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.