IT Specialist

About the role

The role is part of the Biomedical Digital Department, supporting the organization by identifying and delivering operational improvements using new technology and data. It operates in a highly regulated quality and operational environment.

Responsibilities

• Evaluate, develop, and implement procedures following Change Control practices.
• Support QA management during Customer or Regulated Body Audits, addressing software security-related findings.
• Contribute to the assessment of requirements and documentation of software solutions.
• Advise on application development and acquisitions regarding security requirements and controls.
• Collaborate with corporate cybersecurity leadership to stay informed about cybersecurity risks and threats.
• Manage cybersecurity aspects related to technology change control within Biomedical.
• Ensure accurate and timely updates for IT/OT asset inventories and CSOT network diagrams.
• Implement formal processes for asset lifecycle communication and conduct periodic reviews.
• Assess and manage SHE and security aspects related to the position, including adherence to SHE and security requirements.
• Report SHE and security incidents to management and comply with all job-related safety, security, and other training requirements.

Requirements

• AA/AS Degree in Cybersecurity, Systems Engineering, Controls Engineering, or Computer Science.
• Minimum of 5 years of experience in related fields.
• Experience within an FDA-regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry.
• Knowledge of cybersecurity protection best practices and methods.
• Experience with ISO 9001, ISO 13485, and 21 CFR parts 11, 211, and 820.
• Familiarity with emerging trends like Cloud Computing, Software Assurance, and Data Analytics.

Qualifications

• Fluent collaboration skills across business, digital, and external vendors.
• Good knowledge of IT/OT systems, preferably in a Medical Manufacturing, Pharmaceutical, or Engineering Environment.
• Demonstrated ability to evaluate, develop, and implement procedures following Change Control practices.

Skills

• Understanding of industry accepted software life cycle programs and relevant IT/OT and cybersecurity controls.
• Very good knowledge of IT/OT systems, preferably in a Medical Manufacturing, Pharmaceutical, or Engineering Environment.
• Demonstrated ability to evaluate, develop, and implement procedures following Change Control practices.

Benefits

No additional benefits are mentioned in this job posting.

Pay

$$$$ - $$$$/hr on w2

Schedule

1st shift, 84:30