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Description
auto req 10401br
job posting title principal scientist
career category scientific
employee subgroup salaried ft
country (state/region) ireland
location (city) dun laoghaire
amgen job description this dedicated technical expert and leadership position is accountable for providing oversight of packaging, device, delivery system design & engineering, assessment of production line /equipment capabilities, and related suppliers for the ireland site; support of amgen\'s international cold chain for clinical and commercial products.prepare techincal assessments and impact assessments in view of business case elaboration
. deep knowledge of validation processes and requirements applciable to pharmaceutical equipment
. advanced project managements skills with significant record of projects
. collaborate with global strategic sourcing to select and qualify new suppliers
basic qualifications . experience with quailty systems
. incorporate operational excellence and root cause analysis tools into all aspects of the role. master\'s degree in engineering with significant reltaed industry experience
. cost effective solutions to meet site / patient needs based on proactive technology survey and benchmark
, recommend innovative.experience management vendors and suppliers
. familiar with state of the art fully automated and manual prodcution equipment
. knowledge of medical devices and delivery systems with regard to engineering, production as well as the regulations
. familiar with drug delivery devices and systems
. or delivery system, device, proivde techincal analysis of complaints related to package.
key responsibilities:
. responsible for the technical aspects of site projects connected to the packaging lines, and product configurations
, equipment.experience with primary and secondary pharmaceutical packaging
. track record of success within the biopharmaceutical / gmp environment
. ensure appropriate gmp documentation (specifciations, mpc\'s, tpc\'s, change request) is established and approved accodring applicable site procdeures and corproate guidleines
.provide operatoinally related technical supoprt to irealnd production and quality assuarnce (technical reprots, nc investgiation, suplpier assessment and specifications, and compnoent mateirals)
.corporate groups, and effective management of global resources across the network, ensure alignment with across functional groups.national and local regulations on packaging and device requirements
, familiar with international.knowledge of packaging equipment and device assembly equipment
. significant operations experience with demonstrated line management/supervisory skills
. responsible for all process development projects assigned to the group including support to acm\'s when necessary
. this key position will be responsible to ensures that amgen\'s international packaging and processes is or are designed and developed in accordance with current regulatory,
in addition, clinical and gmp guidelines.recommend changes to optimize the performance of material, equipment and processes
. as prescribed in the corporate standard, are implemented for the region
,
. ensure all brand protection features.assure effective technical input and interaction with global networks and functional teams across the manufacturing network
. both in oral and written communication
preferred qualifications, fluency in english.good understanding of pharmaceutical manufacturing supply chain. experience regarding drug product development process and commercialization process
. ensure ongoing technical support and update is given to global marketing and international regulatory affairs (ico) for commercial products and new product launches
.
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