- Reference: GY43756AO
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
Summary: The Process Engineer will work with the Manufacturing Sciences and Technology (MSAT) group based in the US to ensure site to site consistency after processes are transferred. Responsible for providing technical support for internal late stage and commercial manufacturing processes across sites, including engineering support for existing equipment and manufacturing processes. The Process Engineer will also support process transfers into Ireland and partner facilities by assesses manufacturing requirements and facility needs.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Review process data identify and report shifts or outliers.
• Discover opportunities to improve process reliability, repeatability, compliance and consistency.
• Monitor process data and review methods, facilities and equipment design to ensure operational and process consistency.
• Support quality investigations and technology transfer initiatives as a subject matter expert.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Ensure that operations are performed manner consistent with safety standards and within cGMP guidelines.
• Assists in the design review of equipment and facilities.
• Support Process Transfers to external facilities.
• Assist in the assessment of manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
Education and Requirements: BS in Engineering with minimum 6+ years of industry experience; Master’s degree or PhD in a scientific discipline may be considered in lieu of industry experience.
Level will be commensurate with experience.
Knowledge and Skills:
• Experience in large scale cell culture production and purification
• Ability to interpret engineering drawings
• Mechanical aptitude and fundamental understanding of process equipment
• Ability to adapt to a quickly changing environment.
• Solid knowledge of cGMP and other applicable regulations.
• Ability to effectively communicate issues and ideas with peers and with management.
• Ability to facilitate meetings with cross functional teams.
• Demonstrated interpersonal, written, and oral communication skills.
• Ability to build effective working relationships throughout the organization.