Cache of job #13974052

Job Title

Senior Process Development Engineer

Employer

Sigmar Recruitment

Location

Dublin South

Description

Senior Process Development Engineer. Job Responsibilities; The Senior Process Development Engineer will lead 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. The Process Development Engineer will troubleshoots issues with packaging equipment and associated vision systems. Conducts risk assessment for packaging operations and propose / implement CAPA. Identifies and implements operational opportunities for current and new packaging operations. Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. This job will involve developing characterisation Plans, IOQs and PQs. 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. Participate in Qualification Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. Pre-approve and post-approve process characterisation/qualification/validation protocols and assessments from a quality system documentation perspective. The Process Engineer will 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. Job Requirements; A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience is essential. Knowledge of cGMPs and other worldwide regulatory requirements. Direct experience with medical devices/combination products and associated manufacturing processes and vision systems. Excellent written and verbal communication skills together with demonstrated ability to work in a team environment. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Packaging and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections desirable. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.

Date Added

1929 days ago

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