Computer System Validation Engineer

Job Category:
Software Developer/Engineer
Job Type:
Level of IT Experience:
5-10 Years
East Ireland
Salary Description:
Competitive salary offered
Dabster Systems
Job Ref:

We need a candidate who has the basic requirements of computer system validation.

- immediate requirement

- 2 LabX resources each for Carlow (6 months), Ballydine (6 months), and Brinny (6 months) in Ireland

Job Responsibilities (description of the work):
* Act as Validation and Qualification Lead on large laboratory remediation projects, with a specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
* Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
* Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs
* Coordinate alignment of systems users from various company groups on validation and qualification documentation
* Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
* Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
* Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.

Job Qualifications:
* 7+ years of Lab Systems validation experience is required. 10+ years are desired
* Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years' experience with LabX method development and validation preferred.
* Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
* Understanding of Data Integrity concepts is required
* Excellent communication and written skills required

Contact Details:
Dabster Systems
Contact: Raj Singh

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