Specialist IS Business Systems Analyst

What you'll do

• Serve as a subject matter expert in computer system validation (CSV), data integrity, and regulatory compliance.
• Identify opportunities to streamline, optimize, and automate business processes while ensuring adherence to global standards.
• Maintain a state of inspection readiness by developing playbooks, guidance documents, and tracking tools.
• Provide compliance and validation oversight for the implementation of new digital platforms and technologies.
• Partner with cross-functional teams to ensure all systems meet quality requirements and regulatory expectations.
• Collaborate with vendors and third-party providers to design and implement effective support models.
• Analyze system requirements and contribute to the Computerized Systems Lifecycle, including design and integration approaches.
• Track performance metrics and stay current on industry trends to drive continuous improvement in technology services.

What we're looking for

• A Doctorate degree or Master’s degree with 2 years of Information Systems or Engineering experience.
• A Bachelor’s degree with 4 years of Information Systems or Engineering experience.
• An Associate’s degree with 8 years of Information Systems or Engineering experience.
• A high school diploma/GED with 10 years of Information Systems or Engineering experience.
• Prior experience in biotechnology, pharmaceutical, or other regulated industries is preferred.
• Expertise in computer system validation (CSV), regulatory compliance, data integrity, and inspection readiness.
• Strong verbal, written, and presentation skills to engage stakeholders and senior management.
• Ability to manage multiple priorities and resolve complex compliance and validation challenges.