Amgen Engineer - AML7 System Owner in Juncos, Puerto Rico
Are you looking for a challenging new opportunity to test and grow your engineering skills? We have an immediate need for an Engineer-System Owner to join AML7-Drug Substance team. This is an outstanding opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Bulk Manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.
Under general supervision, the Engineer will assist with or directly provide technical engineering support in process optimization strategies, upgrades, replacements, and modifications in the operations, manufacturing, or pilot plant environment. Ensures that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
Supports the manufacturing/quality systems in areas such as non-conformances, process validation, process monitoring, procedures, training, maintenance, calibrations and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. This role is crucial for Amgen’s success and will be a key contributor in F&E organization.
Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.
The AML-7 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, sophisticated equipment engineering and automation, and a culture of opportunities integrating multi-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.
As part of a non-standard shift, the team focuses on planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes.
Specific responsibilities include but are not limited to:
Support non-standard shift manufacturing operations that may include weekends and nights.
Perform standard engineering work requiring application of standard techniques and procedures.
Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.
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.
Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
Routinely audit the operational performance and regulatory compliance of a moderate number of complex equipment items or systems.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Support the plant’s corrective, preventive, and predictive maintenance program. Collaborate with equipment manufacturers and maintenance technicians to define maintenance and calibration requirements.
Review, modify and/or generate standard operating procedures. Provides job instructions and technical advice to comply with standards, codes, best practices, or others as applicable.
Generate and manage equipment/systems change control records and execute CAPA records requirements.
Support equipment/systems validation activities.
Lead and support investigations for Quality deviation events, and support compliance audits.
Support the plant’s environmental, health and safety programs.
Obtain and critique quotes for equipment modifications or installations.
Generate project cost estimates and schedules.
Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
Basic skills and education
Master’s degree in Engineering
Bachelor’s degree in Engineering & 2 years of manufacturing and/or engineering experience in a GMP regulated industry
Beyond that, the preferred qualifications are:
Educational background in Mechanical, Electrical, Chemical, Biomedical, and/or Industrial Engineering
Engineering industry experience
Working knowledge of pharmaceutical/biotech processes.
Experience supporting GMP production operations.
Regulatory knowledge and interactions.
Organizational, technical writing and presentation skills.
Project management skills.
Availability to support non-standard shift.
Excellent communication skills in English and Spanish
Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site childcare and fitness facilities – you will find us focused on 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.