Job Description
A Process Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical Client. This is a 12-month contractor position. If you are interested in working in a Sterile environment and supporting technical transfers, then this is the position for you.
Role of this Position
Deliver projects that fall under the bracket of continuous improvement in existing thawing, formulation, filling, filter integrity testing, and wash/autoclave areas to support NPI and capacity expansion, including single-use technology vendor selection, component introduction, and qualification.
Execute Process Engineering activities (cycle development protocols/reports, project improvements, deviations, problem-solving, change controls, etc.) on schedule and to appropriate compliance and safety standards.
Provide support on existing Aseptic Syringe Filling Lines, which include Debagger/Ebeam/Delid/Deline/Isolator/Syringe filling machine with multi-filling technologies.
Support commercial manufacturing through delivery of key performance metrics (SQDCI). Participate in Regulatory Audits.
Job Requirements
Hold a Degree in an Engineering discipline.
Possess strong problem-solving skills.
Show proficiency in documentation/protocol generation and execution.
Have at least 3 years of relevant experience in a highly regulated GMP environment.
Experience in syringe filling is advantageous.
Able to lead major investigations.
Familiar with Fill Weight Cycle Development for a filling machine.
Experienced in New Product Introduction to sterile manufacturing.