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 inoffice 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: $90,000 - 100,000