Process Development Engineer required for state of the art API manufacturing facility at Grangecastle, Dublin. Will support a new Oncology API product introduction project on the site. 2 year FTC with all benefits.
- Support Technical Transfer of API Products
- Support the delivery of Tech Transfer Schedule
- Author Protocols, Reports and Batch Records (Paper and Electronic)
- Lead disciplined Root Cause Analysis
- Understand Quality requirements and communicate them to the project team
- Understand Safety is the first priority
- Support Process Validation and commercial operational readiness
- ‘Hands on’ support in execution of Process Validation
- Understand equipment operation and provide technical support to the manufacturing team
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services.
- Investigate quality events and prepare deviation reports
- Minimum 3 years experience in Pharma Manufacturing
- Experience of API manufacturing
- Excellent written and verbal communication skills
- Flexible, willing and positive attitude / mind-set
- Excellent planning, scheduling and prioritisation ability
- Excellent documentation skills and attention to detail.
- Excellent knowledge of Microsoft products and systems skills.
- Strong Quality orientation.