CSV Engineer
- Midlands (Ireland)
- Contract
- CAPEX Projects
Our Partner in Waterford develop and supply innovative pharmaceutical products to customers globally. They are undergoing several site upgrades, and require a CSV Engineer to help support projects on a contract basis.
Key responsibilities as a CSV Engineer:
- Partner with local project teams to deliver Automation and IT aspects of capital projects.
- Liaise with site AIT group to add input to site SOP’s.
- AuthorReviewApproval of qualification lifecycle documents for processlab systems
- Work with site teams on generation of requirement andor configuration specification, design specifications and test protocol generation, execution and approval.
- Maintain Inventory and control upgrades to DELTA-V/OEM automation systems.
- Generate any automation change control documentation required for introducing new systems or modifying existing systems.
- Generate any risk assessmentvariance documentation and interface with above site team to close out same.
- Interface with above site teams for deliverables of Enterprise systems as required.
- Ensures that SDLC is appropriately applied.
Experience required as a CSV Engineer:
- BS in Engineering, Computer Science, or other technical degree.
- 3 or more years of experience in project/automation/IT support in a similar role.
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- Excellent facilitation, problem solving, and decision-making skills.
- Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles
- identify appropriate process and technological solutions is essential.
- Experience in Delta-V & OEM Automation systems.
If this CSV Engineer role is of interest to you, please apply now!
#LI-TE1
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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