Software Validation Engineer

Summary of the role

Responsible for ensuring all non-product computerized systems (e.g. ERP, QMS, LIMS, labeling systems, statistical analysis software, manufacturing equipment with embedded software) used in GxP processes are validated, maintained in a controlled state and compliant with the Quality Management System and applicable regulations.

Tasks and Responsibilities 

• Conduct computerized system risk assessment to determine validation scope and and determine appropriate validation rigor.


• Support the selection of new software that aligns with the business and end user requirements.


• Apply risk-based thinking to focus validating efforts on functions that impact product quality, patient safety, and data integrity.


• Develop and execute validation deliverables (e.g., URS, risk assessments, software validation plans, IQ/OQ/PQ, traceability matrices, summary reports).


• Ensure validation activities are compliant to internal quality system requirements, and applicable regulatory requirements (ISO, FDA, EU).


• Support periodic reviews and revalidation assessments.


• Work closely and collaborate with cross-functional teams (IT, Quality, Manufacturing, Engineering, etc) to ensure compliant system operation, and maintain configuration control for validated systems, including documentation of system settings, workflows, security roles, and customizations.


• Evaluate software updates and changes and implement changes through formal change control, including impact assessments, regression testing, and approval workflows.


• Ensure systems remain in a validated state after patches, upgrades, or configuration changes.


• Participate in system implementations, enhancements, and integrations as the computer system validation representative.


• Review supplier documentation, perform supplier assessments, and evaluate vendor validation packages.


• Support installation qualification (IQ) and environment readiness activities.


• Support troubleshooting and deviation investigations related to validated systems.


• Ensure systems comply with 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).


• Verify that audit trails, electronic signatures, security roles, and access controls are properly configured and tested.


• Support internal and external audits by providing validation documentation and subject matter expertise.


• Provide training, mentorship and guidance on computer system validation, data integrity, and regulatory compliance for CSV.


• Stay current with evolving regulatory standards and validation best practices.

Education and Experience

Required

• Bachelor’s degree in Engineering, Computer Science, Software Engineering, or similar disciplines


• 3+ years of experience in CSV, software validation, or quality/compliance in a regulated medical device or pharmaceutical environment


• Working knowledge of




• GAMP 5


• 21 CFR Part 11


• EU Annex 11


• ISO 13485 / 21 CFR 820


• Data integrity principles (ALCOA+)




• Hands-on experience validating non-product systems such as ERP, QMS, LIMS, labeling systems, statistical analysis software, manufacturing equipment with embedded software.  


• Strong communication, documentation, testing and problem-solving skills

Desired

• Experience with cloud/SaaS systems and shared responsibility validation models.


• Experience with project management and test management platforms tools such as JIRA.


• Strong understanding of regulatory requirements and software testing methodologies for the pharmaceutical and medical device industry


• Experience with supplier audits or vendor qualification.


• Ability to work independently and collaboratively in a regulated environment


• ASQ Certification

Competencies

• Strong analytical and critical thinking skills


• Excellent written communication and documentation discipline


• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively


• Ability to read, write, speak and understand the English language


• Ability to work cross functionally and influence without authority


• Detail oriented with a mindset for compliance and continuous improvement


• Comfortable working in a fast paced, highly regulated environment


• Strong familiarity with FDA regulations and guidance for software validation


• Understanding of ISO 13485


• Results oriented – drives progress & excellence


• Ability to demonstrate adequate job knowledge to deliver a world class performance


• Ability to challenge oneself to consistently meet all goals and deadlines


• Willingness to strive for excellence by producing work that is free of errors and mistakes


• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately


• Commitment to making improvements company wide


• Demonstrated competence using Microsoft Office, Project, and Statistical Software


• Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards


• Able to perform math functions


• Effective project leader


• Good hand/eye coordination and depth perception


• Good manual dexterity


• Correctable normal reading distance vision

Geography to cover and travel requirements

• Travel approximately 40% to support global software implementations, attend seminars, global sites, and other events as required


• For the first six months, this role will be fully onsite (Monday–Friday). After that period, the position may transition to a hybrid schedule with three in‑office days per week.

#TMS

• Competitive compensation: Plus, bonus opportunities!


• Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!


• Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!


• Greater opportunity for impact: You will impact the production of life-saving devices.


• Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Base Salary: $95,000 - 105,000