Validation engineers evaluate systems and processes used to build products. They work in several fields, such as pharmaceuticals, biotechnology, or medical devices, among others.
Validation engineers ensure products meet company requirements. They run software test and analyze and document results. Validations engineers monitor compliance with safety and quality regulations.
As a Software Validation Engineer, you will play a pivotal role in ensuring compliance and integrity of computerized systems within and connecting to our medical and pharmaceutical equipment that we manufacture. The Automation Computer Systems Validation (CSV) Engineer will work as a member of the Software Department at Steelco Sp A. This role will provide CSV support leading and executing CSV activities for process automation systems across the several processes and businesses. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life changing products. Steelco Sp A, part of the Miele Group, is today one of the world’s leading manufacturers of cleaning and sterilization systems for healthcare, pharmaceutical, and research laboratories. Continuous innovation, customer dialogue, and flexibility enable the company to raise the bar of excellence every day. Steelco accepts the most complex challenges to create unique solutions customized to the characteristics of each project, loyal to the values that have always guided our commitment.
JOB SCOPE
Define validation strategies for Gx P systems (both stand alone and interfaced systems) and manage the lifecycle of internal Gx P systems, including requirements and system design documents, test protocols, system release documents and maintenance documents (e.g. change control, periodic review, incident management, etc.) in accordance with GAMP5, 21 CF Part 11, Data Integrity and internal SOPs.
KEY RESPONSIBILITIES
In line with the job outlined above, the following are the key tasks that would be expected of the role:

• Provide subject matter expertise for computer system validation and data integrity for automation systems across the different processes including:
• Software verification and validation (it is an integral part of software design that spans all the development stages as specified in IEC 62304 which addresses Software Development Life Cycle (SDLC) of software embedded within medical devices. Software Verification is to test if the software was designed as per requirements and Software Validation is to test is if the right product was built for the user.)
• Support in the stages included in the SDLC (software planning, requirement management, software architecture design, configuration management, software coding, software integration, software V&V, software requirements to risk mitigations to verification traceability, software release and software maintenance activities.)
• Perform risk assessments for equipment control systems and develop strategies to mitigate identified risks
• Draft software/hardware documentation templates
• Review third party software and other software engineer documentation
• Develop and Execute validation protocols for the control systems installed on the different equipment
• Ensure compliance with regulatory requirements (FDA, EMA etc.), industry standards (GAMP, 21 CFR Part 11, Data Integrity etc) and corporate quality policies and procedures
• Generate and maintain validation documentation, such as validation plans and summary reports
• Support audits with customers as needed and represent the Software Department during audits by regulatory agencies
• Support generation of documentation packages as a part of submissions to regulatory agencies such as US FDA.
• Provide training to personnel on CSV principles, procedures and best practices
• Support Quality Engineering in development and creation of policies and procedures for generation of the various SDLC documents.

RELATIONSHIP:
Steelco Group INTERNAL RELATIONSHIP: will be part of the Steelco software development team and provide mainly support for the Medical Devices equipment; will be involved in Steelco Pharma and R&D development team projects too.
Steelco Group EXTERNAL RELATIONSHIP: software and electronic team in the Miele Group (Home Electronic, Cybersecurity)
IMMEDIATE MANAGER: OT MANAGER
WE ARE LOOKING FOR
EDUCATION: Degree in Chemical Engineering, Computer Science, Applied Physics and Instrumentation, Electrical or Electronic Engineering or qualifications in other relevant engineering/science discipline with appropriate experience
EXPERIENCE: 5 years+ working experience in equipment manufacturing for Healthcare industry or electronic medical device (engineering/automation department), Consulting Computer System Company
SKILLS:

• Deep knowledge of GMP (including Annex 11 and Annex 15), GAMP, 21 CFR part 11, computer system validation and data integrity
• Demonstrated ability to participate in and facilitate decision-making.
• Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
• Strong collaborative skills with an ability to work effectively in a team environment
• Demonstrated ability to influence peers and business partners
• Good written and verbal communication skills for both technical and non-technical audiences

PREFEREABLE:

• Experience with audits by regulatory agencies
• Experience in Life Science equipment for use in a GLP or GMP environment / Medical devices according to IEC 62304
• Experience with Automation system administration, Automation networking, Server/Client systems, IEC 61131-3 PLC/HMIs, S88 and S95 architecture design experience, SCADA, MES
• Experience in using software validation tools

Job location: Steelco S.p.A. Via Balegante, 27 - 31039 Riese Pio X - TV - Italy (hybrid work available)
Department: Software
Informativa ai sensi del Nuovo Regolamento UE n. 679/2016
I dati personali riportati nel curriculum vitae verranno trattati da Steelco Spa, con sede legale in Riese Pio X – TV, Via Balegante 27 (“Società”), per la selezione relativa alla presente posizione o ad altre analoghe. Informazioni dettagliate anche in ordine ai diritti riconosciuti dalla normativa in materia di protezione dei dati personali, sono riportate nell’informativa disponibile sul sito internet della Società alla pagina “Lavora con noi” http://www.steelcospa.com/it/?option=com_rsform&form Id=5
Contratto di lavoro: Tempo pieno
Contratto di lavoro: Tempo pieno