Amgen Specialist Manufacturing (12 Month Secondment Opportunity) in Dublin, Ireland
With minimal supervision, ensure development, implementation and maintenance of a robust (i.e. reliable, efficient, effective, compliant and proactive) Aseptic Compliance program for ADL. Responsibilities will also include supporting the execution of manufacturing/quality systems such as non-conformances, CAPAs, 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.
Ensure ADL maintains a strong regulatory reputation in Aseptic Compliance. Ensure development, implementation, and maintenance of a robust (i.e., reliable, efficient, effective, compliant, and proactive) Aseptic Compliance program for ADL. Prepare the site for successful inspections, both external and corporate. -Ensure constant inspection readiness status by engaging actively with the Microbiology Laboratory, Manufacturing areas and other classified areas and ensure any corrective or preventive actions are in place and addressed in a timely and accurate manner. Ensure site compliance with Operating Standards & regulatory requirements specifically for aseptic manufacture. Execution of aseptic compliance audits Analysis and action on environmental trends in aseptic manufacturing areas. Implementation of industry best practice in relation to cleanroom garb and cleanroom behaviour. Provide input as key Subject Matter Expert into significant investigations on site. Keep informed of GMP/GxP and industry trends, requirements, and practices and actively communicate those to all applicable ADL areas. Take an active role in educating staff in compliance expectations and continuously help raise the bar. Take a lead role in design and qualification process of new aseptic manufacturing and support areas. Represent ADL at related network groups and initiatives, such as contamination control network. Works according to Amgen values. Report any accident, near accidents or unsafe working conditions
Act as Site Aseptic Compliance Subject Matter Expert for Inspections and Audits
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.
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.
Bachelor’s degree or equivalent in Microbiology
Typically 10+ years of related professional experience
Strong GMP and other applicable GxP knowledge
Demonstrated experience interacting with regulatory authorities
Demonstrated experience in evaluating and applying compliance requirements/ guidelines to new and real-life situations
Fluency in English
8 years of experience in Microbiology/Aseptic Compliance in sterile pharmaceutical, biotechnology or medical device industry
Previous experience as the primary interface with regulators on matters associated with Microbiology/Aseptic Compliance
Knowledge and experience in performing investigations
Demonstrated experience interacting with and building relationships with key stake holders in Manufacturing, Quality and Engineering