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Validation engineer

Valladolid
Amaris Consulting
Publicada el Publicado hace 11 hr horas
Descripción

Take your career to the next level with Amaris Consulting as a CSV/OEM Automation Engineer.Be part of an international team, thrive in a global group with a €800M turnover and over 1,000 clients worldwide, and an agile environment. The ideal candidate will have a proven track record in building scalable, high-quality applications and is comfortable working across the entire stack.

WHAT WOULD YOU NEED?Bachelor's degree in Engineering, Computer Science or related technical field .3+ years of hands-on PLC/SCADA programming and commissioning in a GMP -regulated pharmaceutical environment.Proven track record applying SDLC methodologies (RS updates, RTM, change control, test protocols, validation reports).Solid understanding of cGMP, CSV (Computer System Validation) and LEAN/Six-Sigma principles.Experience with at least one of the following platforms: Siemens WinCC/S7, Aveva System Platform/Intouch, OSI PI, Kneat .Familiarity with pharmaceutical processes : WFI generation, CIP/SIP, autoclaves, parts washers, filling, packaging, inspection.Strong facilitation, problem-solving and decision-making skills; able to translate user requirements into technical solutions.Ability to build and maintain relationships with OEM vendors and internal IT/security teams (GIO).Fluent English

WHAT WILL YOU BE DOING?Partner with local project teams to scope, design and implement PLC/SCADA changes on OEM equipment.Maintain an accurate inventory of all OEM automation systems and manage controlled upgrades.Execute the full SDLC: authoring quality plans, risk assessments, test protocols, execution and final reports.Commission and validate new or modified equipment, ensuring safe, compliant and high-quality outcomes.Generate and maintain automation documentation (functional specs, wiring diagrams, SOPs, validation dossiers).Educate site teams on automation standards, technology selection and configuration best practices.Establish and monitor SLAs with OEM vendors, ensuring cost-effective support and reliable supply.Coordinate with internal IT (GIO) to guarantee secure, standard implementations aligned with the company's policies.Support field testing, troubleshoot issues and drive continuous improvement initiatives.Update development/test environments as required and manage change control through to production release.

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