Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
Additional Qualifications/Responsibilities
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.
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
