Must have
We are seeking an experienced Compliance Engineer Consultant to support IT compliance and computer system validation activities for a global life sciences client. This role requires hands-on engineering experience executing validation work, supporting compliance documentation, and ensuring computer systems meet applicable quality, regulatory, and documentation standards. The ideal consultant will have experience working in a pharmaceutical compliance environment and will be comfortable performing ground-level execution work while partnering with IT, Quality, Compliance, and business stakeholders.
Job Responsibilities
* Perform computer system validation and IT compliance execution activities for regulated systems in a life sciences environment.
* Support validation deliverables including requirements, risk assessments, test protocols, test scripts, traceability matrices, deviation documentation, and validation summary reports.
* Execute testing and validation activities to confirm systems meet business, technical, quality, and regulatory requirements.
* Identify, document, and support resolution of non-conformances, deviations, compliance gaps, and documentation issues.
* Ensure documentation follows established compliance standards, templates, procedures, and approval workflows.
* Partner with IT, Quality, Compliance, business, and technical teams to understand system functionality, validation needs, and documentation expectations.
* Support review of system changes, enhancements, and releases to assess validation impact and required compliance activities.
* Maintain clear, accurate, audit-ready documentation aligned with applicable GxP, CSV, and quality standards.
* Provide hands-on engineering support for validation execution rather than only managing requirements or project activities.
* Communicate status, risks, issues, and documentation needs clearly to project stakeholders and leadership.
Qualifications
* Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related field.
* Experience as an engineer supporting IT compliance, computer system validation, or regulated systems within the pharmaceutical or life sciences industry.
* Strong understanding of CSV, GxP, validation lifecycle activities, documentation standards, and quality procedures.
* Experience executing validation testing and preparing or reviewing validation documentation.
* Ability to understand system requirements, perform hands-on execution, and document results accurately.
* Experience identifying and documenting non-conformances, deviations, and compliance gaps.
* Strong attention to detail and ability to produce audit-ready documentation.
* Ability to work cross-functionally with IT, Quality, Compliance, business, and technical teams.
* Strong communication, analytical, and problem-solving skills.
* Ability to operate in a fast-paced consulting environment and support client priorities with accountability and professionalism.
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