Senior IT Quality & Compliance Validation Engineer

SABSioux Falls, SD

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Overview

Schedule

Full-time

Career level

Senior-level

Remote

Option for remote

Job Description

The Senior (Sr.) IT Quality & Compliance Validation Engineer is a hands-on position responsible for ensuring the reliability, security, and compliant operation of IT systems in a regulated Life Sciences environment. This position provides day-to-day administration of infrastructure, network and end-user systems while delivering responsive, service-oriented technical support to employees across the organization.In addition to broad operational IT capability, this role is intended to bring greater depth of experience in supporting technology within a regulated GxP life sciences environment. The Sr. IT Systems Specialist will help ensure that IT systems remain secure, compliant, and audit-ready, with particular focus on validated systems, electronic records and signatures, data integrity, and applicable requirements such as 21 CFR Part 11.The role combines strong technical expertise with an understanding of IT compliance and data integrity requirements in regulated environments. The Sr. IT Systems Specialist works to maintain systems in a validated state, supports internal and external audits and ensures IT processes align with applicable regulatory and internal control requirements. This position also serves as a key operational resource within the IT function and provides backup support to the IT Manager to help maintain a stable, secure, and audit-ready technology environment.Duties and Responsibilities (include but not limited to):Compliance and Validation:

Collaborate with QA/RA teams to align IT processes with quality and compliance requirements.
Perform system validation and periodic reviews.
IT Lead for internal and external audits by providing IT compliance evidence and addressing findings.
Act as system administrator for user access controls to all systems including GxP validated and financial systems.
Understanding of GMP, GAMP, FDA (21 CFR Part 11), and other applicable Life Sciences regulations is a plus.

System and Data Integrity

Enforce SOPs, standards, and guidelines to ensure compliant management of electronic records and signatures.
Monitor and remediate issues affecting data traceability or regulatory compliance.
Collaborate with QA/RA teams to ensure IT systems align with quality and compliance needs.

IT Security:

Create, implement and enforce IT security standards and best practices on all servers, laptops, and desktop computers.
Configure, support and maintain IT security tools including Arctic Wolf, ThreatLocker and Microsoft Defender.

Change Management & Risk Mitigation

Administer IT change management processes to ensure that changes to validated systems are properly assessed, documented, and approved.

Conduct post-implementation reviews to confirm continued compliance and validated state.

Documentation, Audit & Regulatory Engagement

Maintain IT compliance documentation.
Participate in internal and external audits, including FDA and SOX-related reviews, ensuring IT compliance posture is well-documented
Lead IT effort through cross-functional collaboration to ensure internal controls structure and compliance requirements are achieved and maintained.

Business Continuity and Disaster Recovery:

Develop, test, implement and ensure ongoing readiness of Business Continuity and Disaster Recovery (BCDR) plans.
Ensure recovery processes align with compliance requirements and maintain validated system states post-recovery.

IT Operations & Network Support

Provide support for the SAB network, assisting with configuration, monitoring, and troubleshooting of IT systems.
Administer Mac/OS, Windows, Android and iOS, MDM.
Maintenance and configuration of 0365 Tennent
Ensure all systems, and applications are up to date, patched and secure.
Maintenance of Active Directory and Entra user accounts and security settings
Maintain up-to-date network diagrams and documentation to support regulatory reviews.
Network administration, assisting with configuration, monitoring, and troubleshooting of IT systems.

Supervisory Responsibilities: This position does not have supervisory responsibilities.Education, Experience and Certifications:

Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field (preferred).
7+ years of progressively responsible experience in IT compliance within a regulated industry (Life Sciences, Pharma, Biotech, or Medical Devices).
Demonstrated experience with validated systems, electronic records/e-signatures, and compliant change control processes preferred.
Hands-on experience with audits (internal, external, and regulatory).
Familiarity with SOX, NIST, and other IT control frameworks is a plus.
Experience with IT infrastructure, including Entra ID, Active Directory, MS365, switches, firewalls, and remote support tools.
Zoho ManageEngine ADAuditPlus and M365 Manager Plus
Strong understanding of compliance in validated systems and electronic data integrity.
Strong troubleshooting, analytical, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities in a regulated environment while maintaining attention to detail.

Physical Demands:While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly lift and/or up to 10 pounds and occasionally lift and/or move up to 40 pounds.Working Environment/Travel:Role can be office based or remote.Must hold a valid driver’s license and have reliable transportation for travel between company locations.This role requires regular travel between SAB’s South Dakota locations and may require occasional travel to SAB’s Miami Beach, FL location.ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets #GXP#ITSpecialist#21CFRPart11

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FAQs About Senior IT Quality & Compliance Validation Engineer Jobs at SAB

What is the work location for this position at SAB?

This job at SAB is located in Sioux Falls, SD, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at SAB?

Employer has not shared pay details for this role.

What employment applies to this position at SAB?

SAB lists this role as a Full-time position.

What experience level is required for this role at SAB?

SAB is looking for a candidate with "Senior-level" experience level.

Does SAB allow remote work for this role?

Yes, this position at SAB supports remote work, giving candidates the flexibility to work outside the primary office location.

What is the process to apply for this position at SAB?

You can apply for this role at SAB either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.