Junior CSV Engineer

Carlow - Ireland

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview

We are seeking a motivated Junior CSV Engineer with a strong interest in automation systems used in pharmaceutical manufacturing. This role supports the validation of automated platforms equipment control systems and associated software to ensure compliance with GxP FDA EU and industry regulations. You will work alongside senior engineers and cross-functional teams to contribute to system qualification documentation and ongoing compliance activities.

Key Responsibilities

Assist in the development and execution of Computer System Validation (CSV) deliverables including URS FRS RTM IQ/OQ/PQ protocols and validation reports.
Support validation activities for automation and manufacturing systems such as PLCs SCADA MES DCS equipment control systems and automated data workflows.
Participate in system testing deviation tracking and change control under GxP frameworks.
Contribute to risk assessments (e.g. GAMP 5 Data Integrity evaluations) for automated systems.
Help ensure system configurations software versions and automation logic are documented tested and maintained according to internal quality standards.
Assist with periodic review system lifecycle management and revalidation activities.
Support cross-functional teams including Automation IT Quality Manufacturing and Engineering during project execution and troubleshooting.
Maintain audit-ready documentation and support internal/external inspections as needed.

Requirements

Bachelors degree in Engineering (Automation Electrical Computer Chemical) Life Sciences Computer Science or related field.
Basic understanding of automation technologies (e.g. PLCs SCADA industrial networks OPC batch systems).
Familiarity with GxP GAMP 5 Data Integrity concepts and regulatory expectations for computerized systems (21 CFR Part 11 Annex 11) is a strong plus.
Strong documentation skills and attention to detail.
Ability to learn quickly in a regulated environment.
Solid problem-solving skills and willingness to work in a hands-on engineering setting.
Strong communication and teamwork skills.

OverviewWe are seeking a motivated Junior CSV Engineer with a strong interest in automation systems used in pharmaceutical manufacturing. This role supports the validation of automated platforms equipment control systems and associated software to ensure compliance with GxP FDA EU and industry regul...

Overview

Key Responsibilities

Assist in the development and execution of Computer System Validation (CSV) deliverables including URS FRS RTM IQ/OQ/PQ protocols and validation reports.
Support validation activities for automation and manufacturing systems such as PLCs SCADA MES DCS equipment control systems and automated data workflows.
Participate in system testing deviation tracking and change control under GxP frameworks.
Contribute to risk assessments (e.g. GAMP 5 Data Integrity evaluations) for automated systems.
Help ensure system configurations software versions and automation logic are documented tested and maintained according to internal quality standards.
Assist with periodic review system lifecycle management and revalidation activities.
Support cross-functional teams including Automation IT Quality Manufacturing and Engineering during project execution and troubleshooting.
Maintain audit-ready documentation and support internal/external inspections as needed.

Requirements

Bachelors degree in Engineering (Automation Electrical Computer Chemical) Life Sciences Computer Science or related field.
Basic understanding of automation technologies (e.g. PLCs SCADA industrial networks OPC batch systems).
Familiarity with GxP GAMP 5 Data Integrity concepts and regulatory expectations for computerized systems (21 CFR Part 11 Annex 11) is a strong plus.
Strong documentation skills and attention to detail.
Ability to learn quickly in a regulated environment.
Solid problem-solving skills and willingness to work in a hands-on engineering setting.
Strong communication and teamwork skills.