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FULL TIME
Salamanca, Spain
Réalta Technologies is looking for an experienced CSV Engineer to support a leading animal health manufacturing facility based in Salamanca, Spain.
This role will focus on supporting validation and compliance activities across manufacturing equipment, automation systems, and machine connectivity solutions within a GMP-regulated environment. The successful candidate will work closely with Automation, Manufacturing, and Quality teams to support system integrations, PLC-connected equipment, and evolving digital manufacturing initiatives across the site.
As the facility continues to progress its Industry 4.0 strategy, there will be increasing focus on PI and PLC-driven automation solutions alongside existing System Platform environments.
Job Responsibilities
Support CSV activities across manufacturing equipment, automation systems, and machine connectivity solutions.
Develop, execute, and maintain validation documentation including validation plans, risk assessments, IQ/OQ protocols, traceability matrices, and summary reports.
Support validation and compliance activities for PLC-connected manufacturing equipment and industrial automation systems.
Assist with troubleshooting, system investigations, and change control activities across automation and manufacturing systems.
Collaborate with Automation, Manufacturing, Quality, and Engineering teams to support system integration and operational readiness activities.
Support ongoing automation and digitalisation initiatives as the site transitions towards increased PI and PLC-driven automation solutions.
Participate in commissioning, FAT, SAT, and qualification activities for new or modified systems.
Ensure all validation activities are completed in line with GMP, GAMP 5, and site quality standards.
Support documentation reviews, SOP development, and audit readiness activities.
Act as a key point of communication for Spanish-speaking stakeholders and project teams where required.
Job Requirements
5+ years’ experience in CSV, validation, or automation compliance roles within regulated pharmaceutical, biotech, medical device, or animal health environments.
Strong experience developing and executing validation documentation within GMP-regulated manufacturing environments.
Familiarity with machine connectivity, industrial automation systems, and PLC-integrated equipment.
Experience supporting validation activities across manufacturing or process systems.
Exposure to PLC troubleshooting and automation systems, with the ability to support investigations and system modifications where required.
Familiarity with platforms such as AVEVA PI, SCADA, MES, or industrial automation systems would be beneficial.
Understanding of GMP, GAMP 5, data integrity, change control, and validation lifecycle activities.
Strong problem-solving and troubleshooting skills within manufacturing environments.
Ability to work cross-functionally with Automation, Engineering, Manufacturing, IT, and Quality teams.
Fluent Spanish is essential, with strong English communication skills also required.
Strong communication, documentation, and stakeholder management skills.