Sr. Engineer, Computer System Validation

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 youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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 Quality Systems and will partner closely with IT QA and various business units (e.g. R&D Clinical Operations and Finance). Occasional travel to other Axogen sites may be required.

Requirements of the Sr. Engineer Computer System Validation

• Bachelors Degree in Biomedical Engineering Information Technology Pharmaceutical Sciences or related field along with 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.
• Strong track record in authoring executing and approving validation documentation across the full software development lifecycle (SDLC).
• Strong understanding of QMS systems and document routing/tracking in a compliance-driven environment.
• Experience managing change controls and periodic review processes.
• Strong verbal and written communication skills able to engage technical and non-technical audiences.
• Familiarity with ERP LIMS MES ELN and SaaS-based GxP systems.
• Formal training or certification in Computer System Validation (CSV) such as courses offered by ISPE NSF CfPIE or equivalent recognized organizations preferred.
• Knowledge of MasterControl or other E-QMS platforms.

Responsibilities of the Sr. Engineer Computer System Validation

The specific duties of the Sr. Engineer Computer System Validation include but are not limited to:

• Develop execute and review risk-based validation strategies aligned with GAMP 5 21 CFR Part 11 EU Annex 11 and data integrity standards.
• Co-author review and/or approve validation deliverables: URS FRS Risk Assessments IQ/OQ/PQ Protocols Summary Reports Traceability Matrices and Data Integrity Checklists.
• Support validation efforts for new and upgraded GxP systems including but not limited to SaaS ERP EBR LIMS MES and QMS platforms.
• 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.
• Elicit document and manage business and user requirements through workshops interviews and process mapping.
• Translate requirements into functional specifications traceability matrices and change controls.
• Serve as a trusted liaison between business stakeholders QA technical teams and external vendors to drive project milestones while ensuring seamless communication and compliance.
• Route and track validation documents and project deliverables in the QMS for review and approval.
• Create 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 system revisions and process changes are appropriately documented and maintained according to regulatory expectations.
• Ensure vendor deliverables meet Axogens internal quality and regulatory standards.
• Identify process gaps propose improvements and advocate for continuous enhancement of validation and compliance practices.

Location (any of these)

APC - 913 Industrial Drive Place Vandalia OH 45377

Tampa HQ -111 West Oak Avenue Tampa FL 33602

Alachua HQ - 13631 Progress Boulevard #400 Alachua FL 32615

Benefits/Compensation

Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.