Amgen Process Development Sr Engineer - Device in Juncos, Puerto Rico
Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Sr. Engineer - Device to join AML’s Process Development Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
The role of the Process Development Sr. Engineer – Device is to independently provide and/or direct the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Also applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering complex projects supporting the Drug Product manufacturing facilities of oral dosage form and parenteral products. Process includes all stages from formulation, filling, inspection, assembly, and packaging. The candidate will develop a deep understanding of the operations to become a subject matter expert to support activities including new product introduction, commercial support, improvement of existing processes and acquisition on new technologies. The candidate will have good documentation skills to write reports that can be used in regulatory audits.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Lead device assembly and packaging equipment selection process.
Work with research, process development and quality assurance to establish combination product testing plans and test methods.
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for device assembly, labeling and packaging systems.
Generate User Requirement Specifications, Design Specifications, Design Review Reports, Factory Acceptance Test protocols, Site Acceptance Test protocols, Commissioning and Qualification reports
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
Develop project budgets encompassing multiple fields for area within project or entirety of smaller project (project management)
Develop technical solutions to complex problems requiring the regular use of innovation and creativity.
Develop and execute protocols in the manufacturing and testing areas.
Generate technical reports and technical assessments
Generate Risk Assessments and FMEAs
Perform equipment troubleshooting
Execute improvement projects at manufacturing areas following Six Sigma
Participate in EHSS (Safety) evaluations
Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
Meet specific project goals and timelines.
Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to complete investigations.
Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)
Supervise, coordinate and review work of a small team on a project basis.
May develop supervisory and mentoring skills.
Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
May represent the department on project teams under supervision of a senior scientific staff member.
Adheres to company policies and procedures to ensure a continuous state of compliance
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Share knowledge to develop the teammates in expertise subject area.
Independently author and review protocols, experiments, scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Generates robust and reliable data in compliance with the respective protocol, methods or SOPs
Monitor field of expertise, including literature and technology development, and communicates observations.
Apply knowledge of scientific/engineering principles and practices outside of area of field expertise to broad variety of assignments in related fields
Basic education & experience
Master’s degree in Engineering and 3 years of experience in a GMP regulated industry
Bachelor’s degree in Engineering and 5 years of experience in a GMP regulated industry
Working knowledge of medical device/combination product/pharmaceutical/biotech processes
Ability to apply engineering science to production.
Specialized equipment/process expertise focused on device assembly and packaging
In-depth knowledge of validation processes and requirements as applied to new equipment installations
Working knowledge of financial analysis tools
Knowledge in medical devices or combination products
Knowledge in vision systems
Knowledge in equipment controls (PLC, HMI, Servodrives, etc)
Knowledge in Lean Manufacturing, Six Sigma or Quality by Design
Knowledge in statistics
Knowledge in metrology
Knowledge in injection molding process
Knowledge of packaging of medical devices or pharmaceutical products
Knowledge in Safety Training (MSDS, Equipment Safety, etc.)
Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.
Fully bilingual in Spanish and English
Demonstrated strong problem solving and conflict resolution
Demonstrated leadership skills, initiative and self-motivation.
Excellent time and project management skills to deliver projects on time and budget.
Great teammate with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
High quality and compliance mind set to work in a highly regulated GMP industry.
Computer literacy (Windows environment: Word, Excel, Power Point, Minitab
Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us passionate about your well-being too.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.