Computer Systems Validation Specialist
In this challenging role, you will be responsible for ensuring the quality and integrity of our systems. Your primary focus will be on delivering top-tier computer systems validation for capital projects, promoting automation validation standards across projects, and collaborating with site compliance and validation teams to coordinate activities.
You will work closely with a cluster lead for the EMEA, Asia-Pacific, or United States region, and report to the Associate Director of Compliance. Key responsibilities include:
* Delivering high-quality computer systems validation results within set deadlines
* Promoting automation validation standards to enhance project efficiency
* Collaborating with site compliance and validation teams to ensure smooth coordination
* Maintaining regulatory compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity
* Serving as a Subject Matter Expert on computer validation for capital projects
* Providing ongoing training and compliance support
* Representing compliance activities to internal and external auditors
* Assisting in developing audit responses and engaging with local quality organizations as needed
* Identifying and addressing IT and Operational Technology compliance risks
* Conducting risk assessments for new technologies or significant changes
* Supporting local teams in navigating quality and compliance challenges
* Reporting on execution challenges and adherence to procedures
* Communicating and advocating for changes to Systems Development Lifecycle policies and procedures
* Participating in a compliance group to share knowledge and improve execution
To excel in this role, you will require:
* Bachelor's Degree in Computer Science, Engineering, Regulatory Compliance, or a related field
* 2+ years of experience in compliance activities for capital projects
* Strong knowledge of regulatory requirements related to computerized systems validation
* Familiarity with ISA S95 and S88 Standards in a Good Practice environment
* Experience validating and qualifying Cloud, Software as a Service, and data integration platforms
* Extensive experience with automation systems and leading validation teams
* Understanding of end-to-end manufacturing processes, including Manufacturing, Quality, and Supply Chain
* Ability to collaborate with diverse stakeholders and manage conflicting priorities
* Excellent written and verbal communication skills, with the ability to simplify complex concepts
* Strategic thinker capable of navigating ambiguity and developing actionable plans
* Self-motivated leader who can drive results with minimal direction
This is an excellent opportunity for individuals seeking a challenging and rewarding career in computer systems validation.
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