Senior Engineer

Senior Engineer

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.

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

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:

• 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
• Developing testing procedures in compliance with regulatory requirements
• 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
• Performing IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) of production equipment
• Analyzing scientific data generated during the execution of production activities such as batch manufacturing records and validation protocols and prepare scientific reports and documents
• Executing Bio-batches (ANDA) and validation batches and to develop pharmaceutical dosage forms using scientific techniques
• Implementing Corrective and Preventive Actions (CAPAs) and change controls using Trackwise, Integrated Document Management (IDM) or Organizational Change Management (OCM) systems

Apply now and make a lasting impact with the Amgen team.