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SDLC Validation Lead
PM Group —Dublin, County Dublin
- Engineering
- English
- No degree
3h

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SDLC Validation Lead

PM Group -
Dublin, County Dublin

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Job details

3 hours ago

Qualifications

Engineering
English
Communication skills
SDLC

Full job description

Due to large scale Biotech project wins we now wish to recruit a Senior CSV Engineer(s) to join a highly skilled PM Group team based a client site.

The following is an example of the day to day activities (however like all large capex projects there will be a good deal of variety).

Commissioning and Qualification of hardware and associated software to support Utility/Process equipment. This includes PLC & SCADA plus interfaces with networks.
Documentation preparation of Commissioning, Qualification and Verification protocols (CQV) for process equipment CSV.
Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for process equipment automation, including Clean & black utilities.
Co-ordination/review of Vendor Automation packages to achieve streamlined CSV
People management

We are interested hearing from engineers with

Intermediate to senior (7+ years) CSV (full lifecycle) experience.
CSV experience of process equipment – Filling lines, Freeze Dryers / Lyos, vial washers & tunnels, cappers, autoclaves, parts washers, storage vessels, etc.
Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices
Experience of working with software/automation validation in a project environment.
A degree level in Engineering, or Science related area
Hands on attitude, specifically functional testing of equipment outlined above.
Excellent oral and written communication skills in English
A high level of customer orientation/understanding

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SDLC Validation Lead

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