Senior Expert, Software Validation and Cybersecurity Exton, PA

Job description

**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 accepted software life cycle programs, IT/OT controls and cybersecurity
+ Fluid collaboration skills across business, digital, and external vendors
+ Very good knowledge of IT/OT systems, preferably in the Engineering Environment
+ Demonstrated ability to evaluate, develop and implement Software QA processes and procedures, large scale validation projects, and design, create, and execute Software Validations for Manufacturing and Quality tooling
+ Experience with ISO 9001, ISO 13485, and 21 CFR parts 11, 211, and 820 a plus
+ Familiar with emerging trends like Cloud Computing, Software Assurance and Data Analytics
+ Well-developed inter-personal and teamwork skills to communicate and resolve software quality 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 dsm-firmenich**

At dsm-firmenich, we don’t just meet expectations – we go beyond them.

Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.

From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions – every single day.

Whether it’s fragrance that helps you focus, alternative meat that’s better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.

And while you’re making a difference, we’ll make sure you’re growing too.

With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders.

Your voice matters here.

And your ideas?

They’re essential to our future.

Because real progress only happens when we go beyond, together.

**Inclusion, belonging and equal opportunity statement**

At dsm-firmenich, we believe being a force for good starts with the way we treat each other.

When people feel supported, included, and free to be themselves, they do their best work – and that’s exactly the kind of culture we’re building.

A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.

We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair and inclusive as possible.

From inclusive language and diverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve.

We welcome candidates from all backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.

And if you have a disability or need any support through the application process, we’re here to help – just let us know what you need, and we’ll do everything we can to make it work.

**Agency statement**

We’re managing this search directly at dsm-firmenich.

If you’re applying as an individual, we’d love to hear from you.

We’re not accepting agency submissions or proposals involving fees or commissions for this role.

Required Skill Profession

Other General