Freelance Computer System Validation Csv Jobs in Kentucky

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.

The Business Systems Engineer - Enterprise Applications position is a hands-on technical contributor responsible for executing and supporting the implementation, integration, and optimization of enterprise and business systems across the organization.

This role bridges business stakeholders, vendors, and IT, ensuring systems are deployed effectively, align with operational needs, and adhere to compliance and validation standards. The Business Systems Engineer - Enterprise Applications works directly with technical environments and configurations—not just project coordination—to help bring systems online efficiently and correctly.

This individual collaborates closely with the Director of Quality Assurance- Computer Systems to ensure implementation activities align with validation requirements and reports to the Associate Director of IT, who oversees enterprise architecture, strategic planning, and IT roadmap execution.

The ideal candidate has experience in the biotech or pharmaceutical industry, particularly in organizations moving from clinical to commercial phases, and understands how to deliver systems that meet both business and compliance expectations.

Key Responsibilities

• Take a hands-on role in configuring, implementing, and supporting enterprise and business systems across departments.
• Work with business stakeholders to capture requirements and translate them into technical and system configurations.
• Lead cross-functional and IS/IT-centric projects, ensuring alignment between business stakeholders, vendors, and internal IT resources.
• Collaborate with IT staff and external vendors to deploy, integrate, and optimize systems that support operational growth.
• Partner with the CSV team to ensure implementation tasks align with validation processes, providing technical assistance (e.g., system setup, environment readiness, data preparation, and issue resolution).
• Support and troubleshoot system integrations, user access issues, and environment dependencies within AWS and Azure ecosystems.
• Participate in data migration and environment setup activities during system deployment.
• Maintain detailed documentation of system configurations, workflows, and change controls.
• Identify and elevate project risks, blockers, or dependencies to the Associate Director of IT.
• Provide post-implementation support and assist in transitioning systems to steady-state ownership.

Qualifications

• Bachelor’s degree in Information Technology, Computer Science, or a related discipline (or equivalent experience).
• Minimum of 5 years of experience implementing or supporting enterprise and business systems in biotech or pharmaceutical organizations.
• Hands-on experience with platforms such as Veeva Vault, ERP systems (e.g., NetSuite, SAP, or Oracle), and cloud environments (AWS and Azure).
• Familiarity with GxP, SOX, and data integrity principles.
• Understanding of both clinical-phase and commercial-phase biotech operations.
• Strong troubleshooting, analytical, and documentation skills.
• Ability to manage multiple priorities and adapt to evolving business needs.
• Excellent communication skills and ability to work cross-functionally across IT, QA/CSV, and business teams.

Core Competencies

Hands-On Executor: Comfortable configuring, testing, and deploying systems directly.

Collaborative Partner: Works effectively with IT, CSV, and business stakeholders to drive compliant implementations.

Analytical Problem-Solver: Identifies technical challenges and implements scalable solutions.

Detail-Oriented: Maintains precision in documentation and configuration management.

Clear Communicator: Provides concise updates and transparent reporting to leadership.

Adaptable: Operates effectively in a fast-paced, evolving biotech environment.

Rezolute (RZLT) currently anticipates the base salary for the Business Systems Engineer - Enterprise Applications role could range from $120,000 to $160,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Rezolute offers competitive compensation, stock options and a rich benefits package.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.