Software Validation Engineer

Sista ansökningsdag 2026-07-24 Plats: USA - Plymouth, MNSummary Of The RoleResponsible 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 ResponsibilitiesConduct 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.RequiredEducation and ExperienceBachelor’s degree in Engineering, Computer Science, Software Engineering, or similar disciplines3+ years of experience in CSV, software validation, or quality/compliance in a regulated medical device or pharmaceutical environmentWorking knowledge ofGAMP 521 CFR Part 11EU Annex 11ISO 13485 / 21 CFR 820Data 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 skillsDesiredExperience 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 industryExperience with supplier audits or vendor qualification.Ability to work independently and collaboratively in a regulated environmentASQ CertificationCompetenciesStrong analytical and critical thinking skillsExcellent written communication and documentation disciplineAbility to communicate clearly by conveying and receiving ideas, information and direction effectivelyAbility to read, write, speak and understand the English languageAbility to work cross functionally and influence without authorityDetail oriented with a mindset for compliance and continuous improvementComfortable working in a fast paced, highly regulated environmentStrong familiarity with FDA regulations and guidance for software validationUnderstanding of ISO 13485Results oriented – drives progress & excellenceAbility to demonstrate adequate job knowledge to deliver a world class performanceAbility to challenge oneself to consistently meet all goals and deadlinesWillingness to strive for excellence by producing work that is free of errors and mistakesDesire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriatelyCommitment to making improvements company wideDemonstrated competence using Microsoft Office, Project, and Statistical SoftwareComprehensive understanding of applicable Work Instructions, SOP’S, and ISO standardsAble to perform math functionsEffective project leaderGood hand/eye coordination and depth perceptionGood manual dexterityCorrectable normal reading distance visionGeography To Cover And Travel RequirementsTravel approximately 40% to support global software implementations, attend seminars, global sites, and other events as requiredFor 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.#TMSAs 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: $90,000 - 100,000Apply here!