Description
CSV Engineer required on an initial 12-month contract basis for a major biopharmaceutical new build project in Dublin, Ireland.The CSV Engineer performs activities to support the computer systems commissioning and qualification and subsequent validation in our clients' new Bulk Drug Substance manufacturing facility being built in BlCo. Dublin.
The successful applicant will develop and contribute to Project Lifecycle and Test documentation and will also assist in the execution of testing for the BDS plant in line with agreed timelines for this key capital project.
The role is a contract position as part of the Automation/MES Team.
Principal Responsibilities
- Technical Application.
- Automation Design, Commissioning, Qualification and Validation documentation - drafting, reviewing and approving CSV related elements of documentation as appropriate.
- Co-ordinate and execute CSV related commissioning, qualification and validation activities where applicable.
- Accountable for scheduling, tracking, reporting and achieving project deadlines.
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Actively contribute to project teams.
- Attends Departmental and Team meetings focused on CSV activities.
- Serve as a CSV representative for internal technical group discussions.
- Understanding and applying industry-specific compliance standards/regulations to all Commissioning/Qualification activities.
- Developing an understanding of the importance considering impact on cGMP and compliance on decisions made.
- Conducting and participating in risk assessments, root cause analysis, and investigations.
- Reviewing, approving and signing off protocols, reports, project change controls and deviations.
- Proactively highlighting any issues around compliance.
- Participates in internal and external audits and inspections where required.
- Proactively keeping up to date with current thinking and best practice.
- Commissioning, Qualification and validation experience in vaccine or sterile product manufacturing and building management would be an advantage.
- Strong technical writing and communication skills.
- Ability to close items to completion.
- Ability to work with a high level of detail and to a high standard.
- Problem-solving skills.
- Project Management skills.
- Experience with ISA S95 and S88 standards.
- Experience in the implementation of a risk-based validation approach as per ASTM E2500, preferred but not required.
- Experience with MES Systems - preferred but not required (Werum PasX, Emerson Syncade, etc.).
- Experience with Process Control & Building Management Systems, preferred but not required.(DeltaV, Siemens, Allan Bradley).
- Experience with OEM Systems, preferred but not required.
- Experience in HPRA/FDA environment.
- Experience in the implementation of a risk-based validation approach as per ASTM E2500, preferred but not required.
- Degree level qualification in Science or Engineering or equivalent.