Software Validation Engineer

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 tests and analyze and document results. Validation 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 SpA. This role will provide CSV support leading and executing CSV activities for process automation systems across 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.

JOB SCOPE

Define validation strategies for GxP systems (both stand alone and interfaced systems) and manage the lifecycle of internal GxP 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 CFR Part 11, Data Integrity, and internal SOPs.

KEY RESPONSIBILITIES

• Provide subject matter expertise for computer system validation and data integrity for automation systems across the different processes.
• Support in the stages included in the Software Development Life Cycle (SDLC).
• 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 engineering 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 the US FDA.
• Provide training to personnel on CSV principles, procedures, and best practices.
• Support Quality Engineering in the development and creation of policies and procedures for the 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 the 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.

Contratto di lavoro: Tempo pieno.