MSD Senior Specialist MS & 

Ireland, Dublin 

836367197

Job Description

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Act as Change control SME for the department and work collaboratively to implement cross functional and franchise impacting changes.
• Represent Process/Materials working with Planning, Procurement, Supplier Quality
• Represent MS&T at Material review board.
• Support project teams, PPQ Parts planning.
• Lead, assist in and facilitate material and foreign matter investigations, ensuring effective Root Cause Analysis and CAPAs, data analysis and interpretation to resolve complex deviations.
• Lead process improvements (with respective to materials) and troubleshooting with end-to-end product focus.
• Lead Proactive lifecycle management of materials onsite including process contact material dual sourcing activities.
• Site Point of contact to the Incoming materials COE
• Lead and coordinate material lifecycle change controls and supplier change notifications for the team.
• Driving direct material optimization projects.
• Provide support to new process introduction or change implementation in commercial manufacturing operations (e.g. E&L assessments, design reviews)
• Provide technical guidance to members of the MS&T team and IPT.
• Lead and/or support various site initiatives to improve compliance status and overall operational efficiency of the site.
• Resolve issues and identify risks in a timely fashion.
• Ensure project milestones are achieved through planning and execution of integrated overall program schedule.

What Skills Will You Need:

• 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 biologics manufacture, facility commissioning, qualification, validation, and startup
• Collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.
• Proven ability to effectively initiate and drive change across the site.
• Strong verbal and written communication skills, project management skills
• Working knowledge of current regulatory requirements and current Good Manufacturing Practices
• Working knowledge of Supplier change notifications.
• Working knowledge of single use components and raw materials

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:10/04/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.