Software Validation Engineer

Location

USA - Northborough, MA

Apply by

2026-07-25

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

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 


Apply here!


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