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
The engineer inspects, measures, analyzes, audits, calibrates and tests the instrumentation, equipment, software and writes procedures per FDA guidance for process validation.
Installation qualification should be 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.
Authoring & reviewing validation documentation e.g. URS, Validation Plans, IQ/OQ/PQs, RTM, GxP & Annex 11 Assessments, VSR.
Capable of generating test scripts to meet the user requirements.
Reviewing vendor protocols, test scripts, and traceability matrix.
Execution of protocols/ test scripts and SOP updates.
Interacts directly with project teams and the associated vendors.
Responsible for assessing the validation impact of changes made to qualified instruments.
Capable of owning issues/deviations and driving them to resolution.
Skills & Experience Required
Good verbal and written communication skills.
5+ years' experience in the regulated pharmaceutical industry.
Must have good interpersonal skills.
Position will require a good deal of interdepartmental interaction and coordination.
Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and EU Part 11 / FDA 21 CFR Annex 11 requirements.
Must possess a thorough understanding of current industry guidance, including GAMP 5.
Experience/Knowledge in qualifying Laboratory and manufacturing applications LIMS, SAP, MES, DeltaV, OSI PI.
Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
Must have 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.
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