Process Engineer - Pharmaceuticals
11-Month Contract Opportunity
We are seeking an experienced Process Engineer to support multiple capital projects at one of our global pharmaceutical clients' sites in Carlow. This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Job Summary:
* Lead and execute production floor-based activities
* Plan and execute C&Q, validation activities as required
* Design, author, review, approve, and execute process development studies in support of new product introduction and ongoing manufacturing support
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations
* Execute equipment qualification validation programs, including re-qualification and re-validation
* Design, author, review, approve, and execute qualification/validation documentation and studies in line with the standard approval process
* Perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis
* Conduct statistical data analysis to support development and commercialization batches
* Support continuous improvement through Lean Six Sigma methodologies
* Lead and participate actively in projects, system failure investigations, and investigation reports
* Execute and develop change controls
* Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues (e.g., FMEA, Fishbone diagrams)
Requirements:
* Prior related work experience, ideally in manufacturing, preferably GMP Setting
* Typically 5 years of related work experience in Aseptic manufacturing/process engineering
* Equipment and process validation
* Sterile filling processes and equipment
* Lean Six Sigma Methodology experience desired