Technical System Owner

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Job Description

• Support the lifecycle management, maintenance, and continuous improvement of IT/OT systems in scope at Pisa site.
• Ensure operational continuity, system availability, and compliance of assigned digital systems within a GxP-regulated environment.
• Execute technical activities related to system configuration, troubleshooting, and integration under DD&T governance.
• Act as a bridge between operations (QC/Manufacturing) and DD&T to ensure effective support and implementation of digital solutions

ACCOUNTABILITIES:  (Describe the primary duties and responsibilities of the job.  Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).

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• Troubleshoot system issues and coordinate resolution with vendors and DD&T teams.
• Support validation and compliance activities (testing, documentation, change controls).
• Contribute to incident, deviation, and CAPA management related to systems in scope.
• Assist in ensuring audit readiness and compliance with GMP and data integrity requirements.
• Support system integration activities between laboratory, manufacturing, and digital platforms.
• Maintain accurate and up-to-date documentation (SOPs, work instructions, system records).
• Collaborate with business users to understand operational needs and provide technical support.

CORE ELEMENTS RELATED TO THIS ROLE:  (Describe what is critical and/or what differentiates this role).

Strong operational focus on system support and execution

Exposure to GxP regulated environment and compliance requirements

Close collaboration with DD&T Lead and cross-functional teams

Technical role with growing involvement in validation and lifecycle management

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Practical knowledge of IT/OT systems, infrastructure, and basic understanding of GMP and computerized system validation principles.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

No formal leadership responsibility; may coordinate activities with vendors or support junior resources when required.

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in       decision-making, complexity of decisions, impact of decisions, problem-soliving)

Operates under defined procedures with moderate autonomy in execution of technical tasks; escalates complex issues.

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external          relationships)

Frequent interaction with:

• Internal: QC, Manufacturing, Quality, Engineering, DD&T global teams
• External: vendors, consultants, system suppliers

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

Supports implementation of digital initiatives and continuous improvement actions driven by DD&T.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

Works across multiple systems in a regulated environment with medium complexity and defined processes.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

1.0  Education

• Technical diploma or Bachelor’s degree in IT, engineering, or related field

2.0  Technical Skills

• IT/OT systems support
• Basic GMP / Data Integrity knowledge
• Troubleshooting and problem-solving
• System configuration and maintenance
• Understanding of validation documentation (nice to have)

3.0  Behavioural Competencies

• Reliability and accountability
• Hands-on, operational mindset
• Team collaboration
• Flexibility and willingness to learn
• Attention to detail

ADDITIONAL INFORMATION:  (Add any information legally required for your country here)

• Role requires operating in a regulated (GxP) environmentMay require participation in audits and inspections supportOn-site presence required for system support activities 

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

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