Cybersecurity Specialist (Biomedical Manufacturing) - Exton, PA

Location: Exton (PA), United States

Department: Manufacturing

Work Location: hybrid

Cybersecurity Specialist

Exton, PA

The role will be part of Biomedical’s Digital Department, supporting the organization by identifying and delivering operational improvements using (new) technology and data. The Cybersecurity Specialist will be a developing specialist in adhering to GxP guidelines and corporate cybersecurity requirements within 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. The role supports the ongoing Biomedical cybersecurity program by maintaining digital asset records, supporting access and configuration reviews, contributing to risk and impact assessments, and assisting with remediation planning.

Key Responsibilities:

• Support the cybersecurity program ensuring that it aligns with corporate and regulatory requirements and contributing to procedures for cybersecurity
• Assist QA management in response to Customer or Regulated Body Audits in all findings related to software security
• Contribute to the assessment of requirements and documentation of software solutions
• Act as an individual contributor and cybersecurity support resource for functional stakeholders, escalating complex questions to appropriate SMEs or leadership
• Support application development and acquisition activities by helping identify cybersecurity requirements, documenting applicable controls, and following up with SMEs or leadership to confirm appropriate implementation and monitoring
• Collaborate with corporate cybersecurity leadership to keep abreast of changing standards or new/emerging cybersecurity risks or threats.
• Collaborate with system owners and stakeholders to maintain cybersecurity aspects related to the change control of technology within Biomedical
• Participate in change control and impact assessments for maintaining digital solutions or evaluating new
• Escalate cybersecurity risks, gaps, and control questions to appropriate SMEs or leadership
• Support digital asset governance and administration of business digital solutions, including inventory maintenance, master data stewardship, user access management, asset lifecycle records, system configuration support, and maintenance of supporting cybersecurity and compliance documentation

We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits.
• A place to grow and develop.
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
• The opportunity to work on growing brands and build on a strong foundation.
• The chance to make improvements and make an impact on the business. 

You Bring:

• AA/AS degree in Cybersecurity, Systems Engineering, Controls Engineering, or Computer Science; 1-3 years of experience in related field; BS degree preferred
• Engineering or Cybersecurity related experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry is preferred, not required
• Understanding of cybersecurity principles, risk management, endpoint protection, access control, asset inventory, and documentation practices
• Familiarity with emerging trends such as Cloud Computing, Software Assurance, Data Analytics, networked systems, identity and access management, and digital asset relationship mapping is a plus. 
• Certifications in cybersecurity methods and standards such as CompTIA Security+ or Risk and Information Systems Control (CRISC) are a plus
• Knowledge of computer system validation is a plus
• Understanding of risk-management, industry accepted software life cycle programs and relevant IT/OT and cybersecurity systems and controls, preferably in a Medical Manufacturing, Pharmaceutical, or Engineering Environment
• Collaborates effectively with business, Digital, Quality, Operations, and external partners with appropriate guidance
• Ability to learn, evaluate, update, and follow procedures in accordance with Change Control practices
• Experience with ISO 9001, ISO 13485, and 21 CFR parts 11, 211, and 820 is a plus