Laboratory CSV Engineer
- Experience Level
- Experienced (non-manager)
We have an immediate requirement for Laboratory CSV Engineer to provide IT support for Quality and Information Systems on site of our global biotech client based in Dublin West.
- Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects
- Liaise with site AIT group to add input to site SOP’s for lab systems
- Author\Review\Approval of qualification documents for lab systems – RS, CS, RTM etc…
- Work with site teams on generation of requirement and\or configuration specification and IOQ test protocols
- Participate in execution of IOQ protocols for lab analytical instruments where required
- Generate any automation change control documentation required for introducing new systems or modifying existing systems for the QO Lab.
- Generate any risk assessment\variance documentation and interface with above site team to close out same
- Work closely with the QAIT function to ensure compliance with Quality standards.
- Interface with above site teams for deliverables of Enterprise systems such as Empower, NuGenisis, Acronis etc
- Ensures that SDLC is appropriately applied
Qualifications & Requirements:
- Bachelos’ degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- BS in Engineering, Computer Science, or other technical degree.
- 3 or more years of experience in project/automation/IT support in a similar role with experience in laboratory analytical instrument qualification.
- Excellent facilitation, problem solving, and decision-making skills.
- Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
- Proven facilitation, meeting/workshop management, project management and change management skills are essential.
- Excellent written and oral communication skills, as well as strong presentation skills.
- Experience with Laboratory systems such as LIMS, Empower and Nugenesis
- Experience in automation equipment used in Laboratory an advantage