CSV ENGINEER

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.

Do you have experience in Programmable logic controllers?, * 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.