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Validation engineer (castilla y león)

León
Amaris Consulting
Publicada el Publicado hace 9 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 integral 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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