Apply for the
Validation Engineer
role at
Westbourne
Location: Limerick, County Limerick, Ireland
Role Summary
Validation engineer is responsible for the qualification of laboratory equipment and associated software by understanding the pharmaceutical manufacturing and quality processes.
This person is responsible to carry out thorough system checks to ensure all the different functions of a device or machine are tested to a predetermined specification before any process or piece of equipment is used in the pharmaceutical laboratory or manufacturing environment.
Role Responsibilities
Inspects, measures, analyzes, audits, calibrates and tests instrumentation, equipment, software and writes procedures per FDA guidance for process validation.
Installation qualification conducted for equipment and software used in a validated process.
Develops and executes all validation deliverables including execution for qualification of equipment and associated software in support of a QC, research or biologics laboratory.
Authors and reviews validation documentation e.g., URS, Validation Plans, IQ/OQ/PQs, RTM, GxP & Annex 11 Assessments, VSR.
Generates test scripts to meet user requirements.
Reviews vendor protocols, test scripts, and traceability matrix.
Executes protocols/test scripts and updates SOPs.
Interacts directly with project teams and associated vendors.
Assesses the validation impact of changes made to qualified instruments.
Owns issues/deviations and drives them to resolution.
Skills & Experience Required
Good verbal and written communication skills.
5+ years' experience in the regulated pharmaceutical industry.
Good interpersonal skills with interdepartmental interaction and coordination.
Thorough understanding of GxPs, FDA and International requirements for computer validation and EU Part 11 / FDA 21 CFR Annex 11.
Knowledge of current industry guidance including GAMP 5.
Experience in qualifying Laboratory and manufacturing applications LIMS, SAP, MES, DeltaV, OSI PI.
Ability to comprehend technical information related to computer software, hardware, and regulatory requirements.
Direct experience with equipment, process and computer validation and determining validation approach.
Education And Skills Required
Engineering, Pharmaceutical Science or Computer Science Degree is preferred.
Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point).
Experience with HP ALM or equivalent software testing/requirements tools.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
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