Cybersecurity Specialist (Biomedical Manufacturing) - Exton, PA

Exton, PA

Full-time

Hybrid

$65K/yr - $75K/yr

Entry Level

dsm-firmenich is a global company focused on bringing progress to life through science and creativity. The Cybersecurity Specialist will support the Biomedical Digital Department by ensuring adherence to cybersecurity standards and mitigating risks in operations technologies and R&D. The role involves maintaining digital asset records, supporting access reviews, and contributing to risk assessments to uphold cybersecurity within the organization.

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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

Qualification

Required

AA/AS degree in Cybersecurity, Systems Engineering, Controls Engineering, or Computer Science; 1-3 years of experience in related field; BS degree preferred
Understanding of cybersecurity principles, risk management, endpoint protection, access control, asset inventory, and documentation practices
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

Preferred

Engineering or Cybersecurity related experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry is preferred, not required
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
Experience with ISO 9001, ISO 13485, and 21 CFR parts 11, 211, and 820 is a plus