IT/Cybersecurity Specialist

Job Responsibilities:

• Verify, record, and correct account access on digital assets
• Update digital asset management inventories based on investigation results
• Engage with the business to define digital asset requirements
• Facilitate or participate in impact assessments for OT, IT, and R&D digital assets and solutions
• Develop plans and execute on the following:
• Assessing site(s) antivirus installation for digital assets or recording justifications after collaborating with area/system owners
• Install antivirus, pending Window patches, or OS security updates as needed; develop process for routine management
• Implement secure network practices by replacing insecure protocols, disabling or securing vulnerable services (Telnet, VNC), and managing Wi-Fi security in compliance with change management processes
• Establish and maintain OT cybersecurity governance by developing a RASCI matrix, assigning event notification responsibilities, and ensuring VLAN cleanup
• Manage and reconcile IT/OT asset inventories and CSOT network diagrams, ensuring accuracy, completeness, and timely updates for system changes or decommissioning
• Implement formal processes for asset lifecycle communication and conduct periodic reviews to maintain integrity of all Systems Under Consideration (SUC)

Skills:

• Biomedical is a market leader in regenerative medicine and in the supply of biomaterials to the medical industry. We have established a team of exceptionally talented and experienced individuals who are committed to innovation, collaboration and improving the medical professional and patient experiences.
• As part of our company strategy, we have identified digital as a key business driver for growth.
• Digital driven growth & Innovation
• Enhance the usage of market and customer data that enables our marketing & sales force in nurturing their relationships with key accounts. Identify new business opportunities for sales and product Innovation, enabled by digital.
• Drive harmonization and automation in our core business processes and drive proactive data orchestration to enable growth, continuous improvement, and operational visibility. This will support both internal and external data collaborations.
• Provide access to digital technologies and data enabling the workforce to become more efficient and effective. We invest in new methods for training and capability building for the workforce of the future.
• Key Areas of Accountability / Responsibility
• You are responsible for maintaining and contributing to the cybersecurity program ensuring that it aligns with corporate and regulatory requirements, defining procedures for cybersecurity, and driving decisions around the direction of the company on the subject matter.
• Assist QA management in response to Customer or Regulated Body Audits in all findings related to software security.
• Contributes to the assessment of requirements and documentation of software solutions
• Act as an individual contributor and trusted advisor to functional stakeholders in matters related to cybersecurity
• Advise in application development and acquisitions to assess security requirements and controls; ensures security controls are implemented and periodically monitored.
• Collaborate with corporate cybersecurity leadership to keep abreast of changing standards or new/emerging cybersecurity risks or threats.
• Manage the cybersecurity aspects related to the change control of technology within Biomedical
• Deep understanding of risk management
• Understanding of industry accepted software life cycle programs and relevant IT/OT and cybersecurity controls
• Fluid collaboration skills across business, digital, and external vendors
• 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
• Experience with ISO 9001, ISO 13485, and 21 CFR parts 11, 211, and 820 is a plus
• Familiarity with emerging trends like Cloud Computing, Software Assurance and Data Analytics is a plus
• Well-developed interpersonal and teamwork skills to communicate and resolve cybersecurity issues with all departments in a global, multicultural, and virtual context
• Demonstrated ability to multitask resulting in positive outcomes for each task assigned
• Proven experience with business process analysis

Education/Experience:

• AA/AS Degree in Cybersecurity, Systems Engineering, Controls Engineering, or Computer Science; Preferred minimum of 5 years of experience in related field
• Engineering or Cybersecurity related experience within an FDA Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry
• Solid understanding of cybersecurity protection best practices and methods
• Certifications in cybersecurity methods and standards such as CompTIA Security+ or Risk and Information Systems Control (CRISC) preferred.
• Knowledge of computer system validation is a plus.