Specialist Manufacturing - AML7 Process Owner

Juncos, PR, US
Sep 19, 2020
Required Education
Bachelors Degree
Position Type
Full time

Are you looking for an outstanding new opportunity to test and growth your Manufacturing skills? We have multiple Specialist Manufacturing roles available that are crucial for Amgen's success and will be key contributors in AML7 Manufacturing area!

With minimal supervision, the Specialist Manufacturing will support the execution of manufacturing/quality systems such as non-conformances, 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.


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, advanced equipment engineering and automation, and a culture of opportunities integrating cross-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 shifts, the team focuses on a range of readiness, setup, manufacturing processing and analytical testing duties supporting Fermentation and Purification activities.


Applied Process Expertise
  • Support non-standard shift organization, including weekends and extended hours as per business needs.
  • Initiate, revise, and approve manufacturing procedures. 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.
  • Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
  • Facilitate and/or support process risk assessments

Process Monitoring
  • 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.

Deviation and CAPA
  • Ensure that all Deviations are triaged within the established goal.
  • Responsible of leading investigations and authoring investigation reports.
  • Responsible for the execution of corrective actions.
  • Responsible of closing Deviations and CAPA's within established goals.
  • Evaluate and report the applicability of CAPA's generated by other areas / manufacturing units.
  • Facilitate and/or support risk assessments associated to Deviations or CAPA's
  • Monitor and communicate incidents trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
  • 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.
  • New Product Introductions (NPI) & 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.

Change Control
  • Initiate and own change control records associated to process and/or manufacturing document modifications
  • Assist manufacturing change owner on CCRB packages impacting the process.
  • Facilitate and/or support risk assessments associated to process changes

Projects and Initiatives
  • Lead and/or participate the ideation process for identification of productivity projects or initiatives.
  • Lead and/or participate on the assessment or implementation of special projects or initiatives.
  • Facilitate and/or support risk assessments associated to projects and initiatives.

  • Bachelor's degree & 5 years of experience in Manufacturing

  • Master's degree & 3 years of experience in Manufacturing

  • Doctorate degree


  • Educational field in Life Science and/or Engineering
  • GMP regulated manufacturing experience
  • Detailed technical understanding of bioprocessing 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
  • Organizational, technical writing and presentation skills
  • Project management skills
  • Knowledge of control charting
  • Availability to support non-standard shift
  • Experience in Root Cause Analysis (Fishbone, 5 Why's, Kepner Tregoe)


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 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 is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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.