Axogen

Healthcare

Sr.Engineer,ComputerSystemValidation

$92–115k Alachua, Florida, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Sr. Engineer, Computer System Validation at Axogen. Skills: Computer System Validation (CSV), GxP, GAMP 5, 21 CFR Part 11, Data Integrity, Validation Documentation, SDLC, QMS. Demonstrate expertise in Computer System Validation (CSV), data integrity, and periodic review of systems. Support validation and compliance efforts for computerized systems with GxP impact”

What You'll Achieve.

Restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care; Lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care; Ensure we deliver improved benefit-to-risk solutions; Guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care

Industry & Context.

Healthcare
Problems you'll solve

Identify any gaps and plan corrective actions; Identify process gaps, propose improvements

Eligibility Requirements

Occasional travel to other Axogen sites may be required, Follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance

What They're Looking For.

Must Have

Bachelor's Degree in Biomedical Engineering, Information Technology, Pharmaceutical Sciences, or related field, 5 years of experience in the Software Industry, specializing in GxP and validated systems, In-depth knowledge of GAMP 5 and 21 CFR Part 11 principles, track record in authoring, executing, and approving validation documentation across the full software development lifecycle (SDLC), understanding of QMS systems and document routing/tracking in a compliance-driven environment, Experience managing change controls and periodic review processes, verbal and written communication skills — able to engage technical and non-technical audiences, Familiarity with ERP, LIMS, MES, ELN, and SaaS-based GxP systems

Nice to Have

Formal training or certification in Computer System Validation (CSV), such as courses offered by ISPE, NSF, CfPIE, or equivalent recognized organizations, Knowledge of MasterControl or other E-QMS platforms

What You'll Do.

Demonstrate expertise in Computer System Validation (CSV)

and periodic review of systems

Support validation and compliance efforts for computerized systems with GxP impact

Coordinate between business units and IT

execute and review risk-based validation strategies aligned with GAMP 5

and data integrity standards

and/or approve validation deliverables: URS

Traceability Matrices

and Data Integrity Checklists

Support validation efforts for new and upgraded GxP systems

including but not limited to SaaS

Manage periodic review of computerized systems by collaborating with Business and System owners to execute the reviews

identify any gaps and plan corrective actions

Maintain and improve the CSV program in alignment with regulatory guidance and regulations

Support internal and external audits related to computerized systems and data integrity compliance

and manage business and user requirements through workshops

Translate requirements into functional specifications

traceability matrices

Route and track validation documents and project deliverables in the QMS for review and approval

manage and/or review change controls in the QMS for system updates or improvements and proactively drive them forward through the full approval lifecycle

Ensure that document updates

and process changes are appropriately documented and maintained according to regulatory expectations

Ensure vendor deliverables meet Axogen's internal quality and regulatory standards

Identify process gaps

and advocate for continuous enhancement of validation and compliance practices

How You'll Work.

Team & Collaboration

Coordinate between business units and IT; Partner closely with IT, QA, and various business units (e.g., R&D, Clinical, Operations, and Finance); Collaborate with Business and System owners; Serve as a trusted liaison between business stakeholders, QA, technical teams, and external vendors

Communication Scope

Verbal and written communication skills; Able to engage technical and non-technical audiences; Seamless communication

Process & Methodology

Manage change controls, Manage periodic review processes, Drive project milestones, Manage validation documents and project deliverables, Manage and/or review change controls

Full Job Description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you’ll love working at Axogen: Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients’ lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Sr. Engineer, Computer System Validation The Sr. Engineer, Computer System Validation, will demonstrate strong expertise in Computer System Validation (CSV), data integrity, and periodic review of systems. This role will support validation and compliance efforts for computerized systems with GxP impact and coordinate between business units and IT, as needed. This position reports to the Supervisor, Qua

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