Control Systems Validation Technician/as

ICDS Recruitment

Galway

Control Systems Validation Technician/Associate Engineer - Galway. Job Description: • Reporting to the Senior Validation Engineer the Computer Systems ValidationTechnician/Associate Engineer will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOP's), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions. The role & responsibilities: • Co-ordinates 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 cGMP's 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 for this role: • 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. • Knowledge 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.

2009 days ago