Job Title: CSV Engineer – Cork based (JO897) – Join Managed Service Team – Cork Site
Job Desc: Zenith Technologies are looking to hire a CSV Engineer to join one of our highly established Managed Services Teams based on a customer site in Cork.
Location: Cork, Ireland
Computer Systems Validation Engineer – new site project, Cork based
Business Unit ZT Site Services
Location of Position Cork, Ireland
Start Date ASAP
Project New site project, Cork based
Experience >2 Years’ Experience
We are looking to hire a CSV Engineer to join one of our highly established Managed Services Teams based on a customer site in Cork. This CSV Engineer will work on behalf of Zenith Technologies and will work as part of the Execution Systems team. This role will start ASAP and the selected candidate will be involved in several new projects.
This is an excellent long-term permanent role and an important position as part of this managed service team.
Qualifications, Experience / Skills:
- A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (Technology Management; Chemical Engineering)
- Over 2 years relevant experience of working on projects within the Pharmaceutical sector
- Experience working with DeltaV, PLC & MES is essential
- OSI-PI experience would be an advantage
Main Responsibilities / Duties:
The activities would include:
CSV Responsibilities for both Projects and Day to Day Managed Service tasks include but are not limited to:
• Global and Site Change Control Impact Assessments
• Automation Change (CQC) Review and Approval
• CSV Deliverables including 21CFR11 Assessments, Annex 11 Assessments, Business Criticality Assessments, GAMP Assessments
• Review and Approval of Automation Designs
• SMTS pre-approval, review and post approval prior to progression to IOQ
• Installation and Operation Qualification Protocol Generation, Execution and Reporting for DeltaV (PAS), PLCs, QBAS, MES, NQBAS
• Maintenance, Review and Approval of site Quality documentation e.g. SLIA, CLIA, System Descriptions, CSV Inventory List
• Yearly commitments made to develop and complete continuous improvements as part of the validation team
• Co-ordination of changes to ensure timely delivery
*Further details on role available to short listed candidates.
Apply through this link or send your CV referencing job order – JO897 to email@example.com or call Patricia O’Brien, Resource Manager in confidence +353 21 4370214, firstname.lastname@example.org . You can also link in http://www.linkedin.com/in/patriciaob
Delivering Automation, Process Control and MES Excellence