Senior Engineer
Senior Engineer
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:
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.
Contact
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
From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
Amgen
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.
Equal Opportunity Employer
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.