Software Validation Engineer

Software Validation Engineer

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 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.

As a valued team member with Trelleborg, you will enjoy:

• 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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.