Computer Systems Validation Specialist
This role involves managing regulatory compliance programs and ensuring adherence to policies and procedures. The ideal candidate will have experience in compliance activities for capital projects, a strong knowledge of regulatory requirements related to computerized systems validation, and familiarity with ISA S95 and S88 Standards.
Key Responsibilities:
* Deliver top-tier computer systems validation for capital projects.
* Promote automation validation standards across projects.
* Collaborate with site compliance and validation teams to coordinate activities.
* Evaluate and ensure compliance with relevant regulations and standards.
* Act as a Subject Matter Expert on computer validation for capital projects.
* Provide ongoing validation, training, and compliance support.
* Represent compliance activities to internal and external auditors.
* Support local teams in navigating quality and compliance challenges.
* Report on execution challenges and adherence to procedures.
* Communicate and advocate for changes to Systems Development Lifecycle policies and procedures.
Requirements:
* 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.