Cache of job #13953061

Job Title

Computer Systems Validation Technician/E

Employer

ICDS Recruitment

Location

Galway

Description

Description: Reporting to the Snr Validations Engineer the Computer Systems Validation Technician will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions. Role & Responsibilities: Coordinates and communicates all testing with affected functional groups and evaluates test results. Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards. Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment. Develop and communicate requirements for quality performance, continuous improvement infrastructure for critical software installations. Write validation plans, reports and procedures. Execute manual tests for software and system validation. Carefully analyse and document test results. Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests. Ensure validation program meets requirements of FDA (21CFR11), ISO, PDMA and GAMP 5 where appropriate. Coordinate and participate in the development, testing and implementation of interim and long-term processes and technology solutions including software testing and system level testing with new software. Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage. Qualifications and Education Requirements: Requires a Level 8 or higher degree in an engineering or science discipline with a minimum of 2-3 years of related experience (medical device/pharmaceutical preferred. Experience in medical device/pharmaceutical industry in the development and deployment of quality systems, process controls and continuous improvement systems. Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA. Knowledge and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control. MS Office competency demonstrated. Excellent interpersonal, verbal and written communication skills. Adaptable and able to work in a fast paced, dynamic work environment. Able to management multiple projects with competing schedules. Knowled of software development methodologies. Knowledge of ERP, database systems and architecture. Knowledge of PLC programming methodologies and systems. This job originally appeared on RecruitIreland.com.

Date Added

1987 days ago

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