Process Development Engineer - Software

Are you looking for a significant new opportunity to test and growth your technical skills? We have an immediate need for a Process Development Engineer - Software 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

The role of the Process Development Engineer - Software is to apply basic engineering principles to the design and implementation of system modifications, experiments and/or projects. The position will support the Drug Product manufacturing facilities of oral dosage form and parenteral products including all process 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 needs good documentation skills to write reports that can be used in regulatory audits.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Technical Responsibilities

• Write codes and understand applications lifecycle
• Provide solutions to a variety of technical problems of moderate scope and complexity by developing and/or modifying applications.
• Function as a technical specialist to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
• Design, build and integrate resources to support data analysis
• Prepare data infrastructure to be analyzed by data scientists.
• Write complex queries for extensive data systems
• Use programming languages to mine and query data, and in some cases use extensive data engines and/or architectures
• Use database architectures, understand machine learning, know how to construct data pipelines, analytics, and use cloud platforms
• Work with data architects to build data solution and/or to be used in company applications/systems

General responsibilities:

• 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)
• 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 expertise to broad variety of assignments in related fields

Basic education & experience

Master's degree in Engineering

OR

Bachelor's degree in Engineering and 2 years of experience

Preferred qualifications

• Educational Background: Computer Science preferable Computer/Software Engineer
• Experience in a GMP regulated industry.
• Work experience in programming, coding, system design and architecture, algorithms and data structures coding languages (e.g. R, MATLAB, SAS, Python) and database languages (e.g. SQL)
• Experience articulating business questions and using programming techniques to establish business solutions
• Able to develop solutions to routine technical problems
• Demonstrated skills in selecting the right tools given a problem
• Excellent communication skills: oral and written. Interacts optimally 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)

The Benefits

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.

Join Us

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.