Job Description 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 Bachelor's 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.