Job Specifications
Job Summary:
The role will be part Biomedical’s Digital Department, supporting the organization by identifying and delivering operational improvements using (new) technology and data. This in the context of our niche and highly regulated quality and operational environment.
In the role, you are a subject matter expert for GXP guidelines and corporate cybersecurity requirements for operations technologies (CSOT) and R&D technologies (CSRD). You will partner with the functional stakeholders to ensure understanding and ownership of their roles to uphold cybersecurity standards and mitigate risk.
Your role will support the digital journey of Biomedical in creating:
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)
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
Knowledge and educational level
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.
Required level of experiences
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 multi-task resulting in positive outcomes for each task assigned
Proven experience with business process analysis
About the Company
Compunnel, Inc., founded in 1994 and headquartered in New Jersey, is at the forefront of providing customized workforce and digital transformation solutions, enhancing the total experience for our valued business allies. Our approach integrates innovative technologies with a human-centric dialogue, exceeding the needs of our customers, employees, partners, and key growth contributors and delivering exceptional value.
With a strategic presence across the United States through over 30 local service delivery centers and glob...
Know more