Process Engineer 18881a
JobTitle Process Engineer 18881A. About Company Our client based in Dun Laoghaire is seeking aProcess Engineer to join its expanding team. Duration of Role 12 months. Summary Objective This role will require the candidate to lead packaging activities for transfer of vial and syringe combination products and the on-going support to Manufacturing. Job Duties • Leads Packaging NPI activities from a Process Development perspective and serves as the Process Development Packaging SME. • Acts as a combination product technical expert to provide solutions when troubleshooting Final Product Technologies (FPT) issues through the NPI or post-NPI phases. • Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing. • Ensuring all aspects of activity within any given Design Transfer adheres to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Pre-approve and post-approve process characterisation/qualification/validation protocols and assessments from a quality system documentation perspective. • Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process. • Assist in deviation and exception resolution and root cause analysis. • Contribute to Product Quality Assessments and process flow documents. Requirements no visa processing Basic Qualifications: SME with Lyo process development, 3 years Experience. Bachelors of Engineering. • Knowledge of cGMPs and other worldwide regulatory requirements. • Experience working with teams and influencing decisions. • Excellent written and verbal communication skills together with demonstrated ability to work in a team environment. BenefitsBenefits of working with Independent Solutions. > Excellent Team of Colleagues. > Access to high-value projects. > Excellent Technical Project Managers. > Excellent pay & conditions. Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland. At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role. We work in the area, we know the business, we are not a recruitment agency! We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles. Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit … This job originally appeared on RecruitIreland.com.
12 days ago