Senior Expert, Software Validation and Cybersecurity - Exton, PA

Senior Expert, Software Validation and Cybersecurity Exton, PA  

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 the technical leader and subject matter expert for software compliance related to computer systems assurance as defined by global regulatory requirements, 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. As member of the Digital Department, you stimulate and introduce new ways of working leveraging the organization’s Digital workplace and drive the adoption across the organization. You support the development and nurture an internal community of digitally minded individuals.

 

The intent is to develop digital capabilities across the core business functions in terms of technology platforms, data literacy and agile ways of working. Aside from the technology angle, data analysis is crucial in our continuous efforts to streamline as well maintain our work processes and systems, predominantly in the Quality, Regulatory and Manufacturing side. Your role will support the digital journey of Biomedical in creating: 

1. An empowered organization enabled by technology and data. Data which is consumable for internal & external collaboration 
2. Drive process and system harmonization that enables Biomedical to scale easily with its international growth strategy.
3. Support the organization in transforming their paper-based way of working into a Digital First mindset when it comes to information handling and consumption.
4. Driving new business opportunities in product innovation by co-shaping the future of biomaterials enabled with digital capabilities.

  Key Responsibilities:

• Managing a software validation program that aligns with global regulation requirements, defining procedures for computer system validation and assurance, and drive decisions around the direction of the company on the subject matter.
• Lead software validation implementation and any additional QA requirements through effective planning of set up, design and testing.
• Design, create, execute, and approve Software Validation Protocols for Quality Related Software, Engineering Tooling and Laboratory Equipment, including a full software lifecycle that concentrates on the creation of software requirements, software hazard analysis and software testing.
• Assist QA management in response to Customer or Regulated Body Audits in all findings related to software quality or security.
• Contributes to the assessment of requirements and documentation of software solutions
• Act as a trusted advisor to functional stakeholders in matters related to software validation and 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

  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:

• BS Degree, preferably in Software Engineering, Biomedical Engineering, Systems Engineering, Controls Engineering, Cybersecurity, or Computer Science
• Minimum of 5 years of 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 
• Deep understanding of quality risk-management concepts
• In-depth understanding of industry accepte