CSV ENGINEER

Description

Summary: Experienced CSV Engineer sought to support validation and compliance activities across manufacturing equipment, automation systems, and machine connectivity solutions in a GMP-regulated animal health facility. Highlights: 1. Support validation and compliance activities in a GMP-regulated environment 2. Collaborate with diverse teams on system integration and operational readiness 3. Engage with evolving digital manufacturing and Industry 4.0 initiatives **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.