Description
CSV Engineer needed for a 6 month contract role in Dublin.
See below the job specification for this role:
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
Qualifications
- Commissioning, qualification and validation experience in vaccine or sterile product manufacturing and building management would be an advantage (min 3 - 5 years)
- 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
If interested please send a copy of your current CV, daily rate and availability.