Cybersecurity Specialist (IT Specialist/Expert)

Job Description

Job Description

Duration: 09 months (Possibility to extend)

Shift: 1 st Shift (08:00 AM – 04:30 PM EST)

 

 

Education:

· AA/AS Degree in Cybersecurity, Systems Engineering, Controls Engineering, or Computer Science; Preferred minimum of 5 years of experience in related field

 

Top 3 Skills:

· Understanding of industry accepted software life cycle programs and relevant IT/OT and cybersecurity controls.

· 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.

 

· Interview Process: 1-2 Teams Interviews

 

Purpose of the job:

· 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:

o Assessing site(s) antivirus installation for digital assets or recording justifications after collaborating with area/system owners

o Install antivirus, pending Window patches, or OS security updates as needed; develop process for routine management

o 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)

 

Job Context:

· Biomedical is a market leader in regenerative medicine and in the supply of biomaterials to the medical industry. We have established a team of exceptionally talented and experienced individuals who are committed to innovation, collaboration and improving the medical professional and patient experiences.

 

As part of our company strategy, we have identified digital as a key business driver for growth.

 

The digital strategy has identified three focus areas:

Digital driven growth & Innovation:

· Enhance the usage of market and customer data that enables our marketing & sales force in nurturing their relationships with key accounts. Identify new business opportunities for sales and product Innovation, enabled by digital.

 

Operational visibility & Efficiency:

· Drive harmonization and automation in our core business processes and drive pro-active data orchestration to enable growth, continuous improvement, and operational visibility. This will support both internal and external data collaborations.

 

Digital Workforce Enablement:

· Provide access to digital technologies and data enabling the workforce to become more efficient and effective. We invest in new methods for training and capability building for the workforce of the future.

 

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.

 

SHE & Security:

· Good SHE behavior is key, so making sure to adhere to the SHE requirements, reporting SHE incidents or near misses and applying the information security requirements are key.

· It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.

· Identifies all relevant SHE and security aspects and assesses the corresponding risks related to position (e.g. use of machines, traveling, required training, ergonomics, SHE plans etc.); acts in such a way that the SHE and security impact on him/herself and others is minimized (e.g. following instructions/procedures, knowing location of fire extinguishers, good housekeeping, document classification and handling etc.) reports and gives follow-up to any incidents (near misses, injuries, dangerous occurrences etc.)

· Complies with all job-related safety, security and other training requirements.

· Report any SHE and Security incidents (including observed risks) to management.

· Show behavior in line with the SHE and Security risks and agreed controls, including being compliant to Biomedical requirements, rules and procedures.

· Comply with all Life Saving Rules.

 

Complexity of the job:

· This job requires a combination of analytical and conceptual capabilities. You are hands-on and involved in the daily operation cross technology platforms. The role will interact with external and internal stakeholders including Innovation, Sales, Quality, Manufacturing, Digital and Tech, and external technology partners. You operate in a global, organization where virtual collaboration is a key to be successful. The role needs to collaborate intensively with Quality Engineers, QA, QC, Business Managers, Project Managers, Manufacturing, Operations, and all other departments to assure our cybersecurity needs are met. Additionally, the role will require regularly scheduled collaboration with corporate functions such as Group Operational Excellence (GOE) and Digital &Tech to stay aligned and ahead on changing trends and policies.

 

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.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.\r\n\r\nAs a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.