Amgen Manufacturing Specialist in Dun-Laoghaire-Rathdown, Ireland
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, CAPA's, change controls, 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.
Non-Conformance and CAPA
Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Accountable for meeting deadlines on all assigned compliance related actions.
Applied Process Expertise
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.
May participate in regulatory inspections
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.
Assist manufacturing change owner on CCRB packages impacting the process. May own change controls
Projects and Initiatives
Participate on the assessment or implementation of special projects or initiatives.
B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.
5 years' related and increasingly complex 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.
Good project management skills.
Basic knowledge of control charting.