Specialist Manufacturing – AML6 NC/CAPA
US – Puerto Rico – Juncos
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances (NC/CAPA), 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. This role is crucial for Amgen’s success and it will be a key contributor in AML6 Drug Substance Facilities supporting an administrative shift Manufacturing area.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
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.
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.
Non-Conformance and CAPA
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Assist with generation and execution of process validation protocols and reports.
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.
Assist manufacturing change owner on CCRB packages impacting the process.
Projects and Initiatives
Participate on the assessment or implementation of special projects or initiatives.
Bachelor’s degree & 5 years of Manufacturing experience in a Pharmaceutical, Medical Devices and/or Biotechnology industryOR
Master’s degree & 3 years of Manufacturing experience in a Pharmaceutical, Medical Devices and/or Biotechnology industryOR
Education discipline in Life Science and/or Engineering.
Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe).
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.
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 leverages 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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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