Amgen Specialist Manufacturing in Juncos, Puerto Rico
The Specialist Manufacturing role will support the execution of manufacturing/quality systems such as change controls, deviations, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems in AML-14 Manufacturing Areas that can include any of the following: Component Preparation, Dispensing, Thawing, Formulation, Analytical Laboratory, Vial Filling and Syringe Filling.
Your main responsibilities:
Applied Process Expertise
Initiate, revise, and approve manufacturing procedures, supporting documentation or protocols.
Ensure all procedures reflect current operations.
Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data.
Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support or assist in the evaluation of atypical events in the manufacturing area.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Deviations and CAPA
Ensure that all deviations are triaged within the established goal.
Responsible to support investigation reports, Root Cause Analysis and CAPA identification to avoid recurrence of the events.
Responsible for execution of corrective actions related to the manufacturing process.
Responsible for managing and closing Minor Deviations, CAPA and CAPA EVs within established goal.
Review equipment/system investigations and support trend evaluations.
Assist with generation of process validation protocols and reports.
Assist with the execution of the process validation.
Support collection and analysis of process validation data.
- May participate in regulatory inspections providing tours, providing supporting information, presenting a specific topic to auditors among others.
New Product Introductions & Process or Equipment Modifications
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Responsible for managing and closing Change Control records within established goal as change control owner.
Assist change owners with assessment of impact to the area, revision and approving manufacturing documentation or in CCRB packages impacting the process.
Projects and Initiatives
- Participate on the assessment or implementation of special projects or initiatives.
You will Need:
Master’s degree and 3 years of Manufacturing Operation experience.
Bachelor’s degree and 5 years of Manufacturing Operation experience.
Beyond that, you will also need:
Educational background in Life Sciences or Engineering
Detailed technical understanding of bio processing unit operations.
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Participate and help lead cross-functional teams
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Good communications skills (oral and written) and comprehend in English and Spanish
Organization, technical writing and presentation skills.
Basic project management skills.
Basic knowledge of control charting.
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 a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance and wellness program – and on-site child care 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.
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.