The role:
PE Global is currently recruiting for a Senior Process Engineer (MS&T) on behalf of a leading biotech company based in Dublin North. This is an initial 6-month contract role.
Job Purpose:
A new position has arisen in our growing Manufacturing, Science & Technology (MS&T) team for a 6 month contract for a Senior Process Engineer to support Upstream Manufacturing.
This role provides exciting and interesting opportunities to work on multiple projects, ranging from manufacturing support activities to new product introductions and technology transfers to regulatory submissions. The role will deliver a diverse range of technical expertise and support to the Business.
Responsibilities:
* Lead, assist in and facilitate investigations, ensuring effect Root Cause Analysis and CAPAs, data analysis and interpretation to resolve complex cell culture deviations.
* Lead process improvement and troubleshooting with end-to-end product focus.
* Support the industry 4.0 initiative to navigate operations and data analytics in a digital environment.
* Provide technical support to new process introduction or change implementation in commercial manufacturing operations.
* Author and review batch documentation, technical reports and supporting global regulatory submissions as needed.
* Provide technical guidance to members of the process engineering team and IPT
* Support execution, data analysis and interpretation of trends observed in commercial process monitoring (e.g., proactive process analysis, continued process verification, statistical process control, multivariate analyses)
* Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site
* Lead and/or support the execution of development and PPQ batches
* Resolve issues and identify risks in a timely fashion. Ensure project milestones are achieved through planning and execution of integrated overall program schedule
Education and Experience:
* This role requires an experienced individual with a degree (or higher) in Science, Engineering, Technical or equivalent
* Minimum 6 years operational support (or 4 years plus Tech Support) in Biopharma industry, with direct experience of USP biologics manufacture, facility commissioning, qualification, validation and startup
* Strong Experience with Upstream processing and troubleshooting including Tech Transfer, regulatory filing, and commercial manufacture
* Experience in leading complex investigations
* Experience in supporting regulatory inspections
* Working knowledge of current regulatory requirements and current Good Manufacturing Practices
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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