Trelleborg leverages in-depth materials and applications expertise with early market insights, making the Group a world leader in engineered polymer solutions. We offer a unique portfolio covering a broad range of applications – even the most complex ones. In 2025, Trelleborg Group reported annual sales of approximately SEK 34 billion, with operations in around 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions, and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is traded on Nasdaq Stockholm, Large Cap. [www.trelleborg.com] (https://www.trelleborg.com/)
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
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Conduct computerized system risk assessment to determine validation scope and and determine appropriate validation rigor.
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Support the selection of new software that aligns with the business and end user requirements.
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Apply risk-based thinking to focus validating efforts on functions that impact product quality, patient safety, and data integrity.
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Develop and execute validation deliverables (e.g., URS, risk assessments, software validation plans, IQ/OQ/PQ, traceability matrices, summary reports).
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Ensure validation activities are compliant to internal quality system requirements, and applicable regulatory requirements (ISO, FDA, EU).
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Support periodic reviews and revalidation assessments.
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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.
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Evaluate software updates and changes and implement changes through formal change control, including impact assessments, regression testing, and approval workflows.
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Ensure systems remain in a validated state after patches, upgrades, or configuration changes.
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Participate in system implementations, enhancements, and integrations as the computer system validation representative.
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Review supplier documentation, perform supplier assessments, and evaluate vendor validation packages.
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Support installation qualification (IQ) and environment readiness activities.
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Support troubleshooting and deviation investigations related to validated systems.
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Ensure systems comply with 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
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Verify that audit trails, electronic signatures, security roles, and access controls are properly configured and tested.
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Support internal and external audits by providing validation documentation and subject matter expertise.
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Provide training, mentorship and guidance on computer system validation, data integrity, and regulatory compliance for CSV.
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Stay current with evolving regulatory standards and validation best practices.
Education and Experience
Required
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Bachelor’s degree in Engineering, Computer Science, Software Engineering, or similar disciplines
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3+ years of experience in CSV, software validation, or quality/compliance in a regulated medical device or pharmaceutical environment
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Working knowledge of
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GAMP 5
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21 CFR Part 11
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EU Annex 11
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ISO 13485 / 21 CFR 820
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Data integrity principles (ALCOA+)
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Hands-on experience validating non-product systems such as ERP, QMS, LIMS, labeling systems, statistical analysis software, manufacturing equipment with embedded software.
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Strong communication, documentation, testing and problem-solving skills
Desired
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Experience with cloud/SaaS systems and shared responsibility validation models.
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Experience with project management and test management platforms tools such as JIRA.
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Strong understanding of regulatory requirements and software testing methodologies for the pharmaceutical and medical device industry
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Experience with supplier audits or vendor qualification.
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Ability to work independently and collaboratively in a regulated environment
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ASQ Certification
Competencies
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Strong analytical and critical thinking skills
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Excellent written communication and documentation discipline
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Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
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Ability to read, write, speak and understand the English language
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Ability to work cross functionally and influence without authority
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Detail oriented with a mindset for compliance and continuous improvement
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Comfortable working in a fast paced, highly regulated environment
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Strong familiarity with FDA regulations and guidance for software validation
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Understanding of ISO 13485
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Results oriented – drives progress & excellence
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Ability to demonstrate adequate job knowledge to deliver a world class performance
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Ability to challenge oneself to consistently meet all goals and deadlines
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Willingness to strive for excellence by producing work that is free of errors and mistakes
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Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
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Commitment to making improvements company wide
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Demonstrated competence using Microsoft Office, Project, and Statistical Software
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Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards
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Able to perform math functions
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Effective project leader
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Good hand/eye coordination and depth perception
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Good manual dexterity
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Correctable normal reading distance vision
Geography to cover and travel requirements
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Travel approximately 20% to support global software implementations, attend seminars, global sites, and other events as required
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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:
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Competitive compensation: Plus, bonus opportunities!
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Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
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Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
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Greater opportunity for impact: You will impact the production of life-saving devices.
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Growth and advancement: Join a global company that loves to promote from within and allows for advancement.
Base Salary: $100,000 - $110,000
