Senior CSV Analsyt

Position: Senior CSV Analyst

Engagement Type: 12‑Month Contract

Target Start Date: Late April

Pay Rate: $65/hour

Location: Concord, North Carolina (fully on-site)

Site Environment: Commercial pharmaceutical manufacturing (multiple production lines, active expansion)

Position Overview

Brooksource Technology & Engineering Services is seeking a CSV Analyst & Project Lead to support a commercial pharmaceutical manufacturing site undergoing continued scale‑up. The site has successfully brought multiple commercial manufacturing lines online and is actively commissioning and validating an additional line. This phase of growth is generating a high volume of system changes, deviations, and data integrity considerations across both equipment and computerized systems.

This role requires strong Computer System Validation (CSV) execution capability paired with demonstrated project ownership. The consultant will play a critical role in supporting validation activities while coordinating closely with site technical subject matter experts and cross‑functional stakeholders to ensure compliance, data integrity, and audit readiness.

Description of Services and Milestones

In collaboration with and at the direction of site leadership, the Consultant will support validation activities for both local and global systems. This includes coordinating technical evaluations with site technology subject matter experts for new and existing systems from a Data Integrity (DI) and CSV perspective.

Milestones and Deliverables

CSV Analyst / Project Lead Responsibilities

The Consultant will support local SMEs and ensure Data Integrity and local validation deliverables are executed and maintained at the site. Deliverables include, but are not limited to:

1. Creation, maintenance, and ownership of all local validation deliverables for site systems.
2. Development of a Site Validation Agreement and Validation Summary Report.
3. Creation and maintenance of Security Plans, Security Administration documentation, Business Continuity Plans (BCP), and Disaster Recovery Plans (DRP).
4. Authoring and execution support of Installation Verification Instructions (IVI) and IQ/OQ documentation for computerized systems.
5. Development of Test Plans, as required, based on system risk and lifecycle state.
6. Authoring and execution of ALM test scripts.
7. Utilization of quality and IT service management systems (e.g., ServiceNow, TrackWise) to create and manage Change Requests, Deviations, Incidents, and Problems.

Scope of Services

Consultant personnel will perform the following high‑level activities:

• Support validation activities for local and global computerized systems.
• Develop and maintain validation documentation including validation plans, protocols, test scripts, and summary reports in alignment with company SOPs and regulatory requirements.
• Coordinate technical evaluations with site technology and automation subject matter experts for new and existing systems from a CSV and Data Integrity perspective.
• Lead and coordinate validation‑related activities across cross‑functional teams to ensure alignment, issue resolution, and timely delivery.
• Perform Data Integrity gap assessments and contribute to remediation plans for computerized systems.
• Create and manage CAPAs, Deviations, and Change Requests within electronic quality systems.
• Provide day‑to‑day project ownership for assigned systems, acting as the primary CSV point of contact through change and validation events.

Required Experience and Qualifications

• Proven experience executing CSV activities within a GMP manufacturing environment.
• Strong understanding of Data Integrity principles and regulatory expectations.
• Demonstrated ability to author, execute, and maintain validation documentation end‑to‑end.
• Hands‑on experience working within electronic quality and IT service management systems (e.g., track deviations, CAPAs, and changes).
• Ability to lead workstreams, coordinate SMEs, and manage competing validation priorities during active manufacturing operations.

Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.