Senior Engineer

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 Engineer

Duties: Write test protocols, perform technical evaluations and submit technical assessment reports to justify the use of selected materials and write Technical Specifications; Evaluate, recommend, and select new packaging materials for both large and small molecules product; Assess complex problems relating to materials, recommending and implementing solutions; Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes; Establish priorities to ensure all projects are managed within expected due dates; Lead and present new packaging ideas, concepts and design ideas to the Product Development team; Ensure cGMP and regulatory compliance are met and ensure that change control procedures are followed working with Quality Assurance and Regulatory to implement changes; Collaborate with multi-functional teams such as Research, Quality Assurance and Quality Control, Supply Chain, Maintenance, Manufacturing, and Regulatory in pre-commercial and commercial activities. May telecommute.  

Requirements: Master’s degree (or foreign equivalent) in Pharmaceutics, Chemical Engineering, or related field & 3 years of experience in the job offered or in an pharmaceutics-related occupation. Position requires 3 years of experience involving the following:  

1. Research and development relating to the manufacturing of various dosage forms by performing scientific analysis and lab testing or analyzing and executing commercial and validation batches of solid dosage forms; 

2. Developing testing procedures in compliance with regulatory requirements;  

3. Following established guidelines or plans to ensure effective implementation of quality management system as per cGMP (Good Manufacturing Practices) and regulatory requirements at all levels of manufacturing; 

4. Performing IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) of production equipment; 

5. Analyzing scientific data generated during the execution of production activities such as batch manufacturing records and validation protocols and prepare scientific reports and documents; 

6. Executing Bio-batches (ANDA) and validation batches and to develop pharmaceutical dosage forms using scientific techniques; and 

7.  Implementing Corrective and Preventive Actions (CAPAs) and change controls using Trackwise, Integrated Document Management (IDM) or Organizational Change Management (OCM) systems. 

Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-244943 

Job type: Full Time position. The annual salary for this position in the U.S. is $133,432.00– $156,257.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/  

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.

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 and make a lasting impact with the Amgen team.

careers.amgen.com

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.

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.

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