CSV Analyst

Job Title: CSV Analyst

Location: Concord, NC

Industry: Pharma

Job Overview:

We are seeking a highly skilled CSV Analyst to support validation activities for both local and global systems within our organization. This role requires expertise in developing, maintaining, and executing validation documentation to ensure compliance with company Standard Operating Procedures (SOP) and regulatory standards. You will collaborate closely with cross-functional teams and subject matter experts to coordinate technical evaluations and ensure effective validation of computerized systems.

Key Responsibilities:

• Develop and maintain validation documentation, including validation plans, test protocols, test scripts, and summary reports, ensuring alignment with company SOP and regulatory requirements.
• Coordinate technical evaluations with site SMEs to assess new and existing systems from a Data Integrity (DI) and Computerized Systems Validation (CSV) perspective.
• Ensure alignment of validation activities with cross-functional teams to meet project timelines and regulatory expectations.
• Perform data integrity gap assessments and develop remediation plans for computerized systems as necessary.
• Create CAPAs/Deviations and Change Requests using ServiceNow and Trackwise, ensuring comprehensive documentation and resolution of issues.
• Utilize HP Application Lifecycle Management (HPALM) for authoring and executing test scripts, maintaining accurate records of testing activities and results.
• Support computer validations associated with Software Development Life Cycle (SDLC) deliverables.

Requirements:

• Bachelor’s degree in a relevant scientific or technical discipline.
• Minimum of 5 years of experience in a validation role within a regulated industry, with strong knowledge of FDA regulations and CSV principles.
• Proven track record of working with cross-functional teams in a collaborative environment.
• Experience in creating ALM test scripts for validation activities.
• Familiarity with Trackwise and ServiceNow for managing CAPAs, Deviations, and Change Requests.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent communication skills, both written and verbal.
• Ability to thrive in a dynamic and fast-paced environment.

Preferred Qualifications:

• Certification in validation (e.g., Certified Validation Professional (CVP) is a plus.
• Experience with other validation tools and systems.

Best-In-Class-Benefits:

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:

• Robust Health Insurance
• 401(k) plan
• PTO accrual
• Paid holidays
• Excellent cash-based referral program

About Theoris:

Our goal is to Fuel Your Career As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.