Description
One of the world's leading Bio Pharmaceutical companies based In West Dublin are seeking a process scientist.€45,000-€50,000 salary alongside pension, bonus and healthcare on offer with the role.
Job Purpose:
A key member of the Technical Services team delivering technical solutions to meet the site business objectives and patient needs. The role requires the flexibility to quickly move from one area to another or to manage multiple projects at the same time. This role focuses on key site activities such as the execution of validation studies, process monitoring, trouble-shooting, leading process investigations and the implementation of cost reduction projects.
Key Activities Include:
- Lead major process investigations and support the implementation of CAPAs.
- Implementation of process improvements in line with yield, process robustness and advances in technology.
- Carry out process monitoring of commercial processes and work to improve process capability where weaknesses are identified.
- Liaise with site functions - QA, QC, Operations, Regulatory Affairs to support manufacturing, regulatory filings and process transfers
- Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues.
- Process validation execution in support of major process changes
- Support Compliance Inspections and enquiries from Regulatory Agencies
- Prepare and execute process and cleaning validation protocols.
- Provide technical training on process and technology areas as required by the project.
Education/Experience:
- Ability to independently plan and perform work assignments, interpret and present data.
- Capability of working in a multi-disciplinary team environment.
- Demonstrated aptitude for technical learning and problem solving.
- Evidence of problem-solving/trouble-shooting skills
- Experience of process and cleaning validation execution preferred.
- cGMP industrial experience, ideally covering some aspects of Operations, Engineering, Projects or Validation within bioprocess manufacturing.
If you are interested in the company and role please contact me Anna Mooney .
For immediate consideration reply with an up to date CV.