Computer Systems Validation; CSV Analyst

Computer Systems Validation (CSV) Analyst Brooksource Technology & Engineering Services

Supporting a Leading Pharmaceutical Manufacturing Partner

• Brooksource Technology & Engineering Services is seeking a Computer Systems Validation (CSV) Analyst to support a premier pharmaceutical manufacturing partner in Concord, NC.
• This role sits at the intersection of manufacturing, quality, technology, and digital transformation, helping ensure regulated systems are compliant, reliable, and fit for use.
• The ideal candidate brings a balance of technical validation expertise and strong stakeholder communication skills, with experience supporting paperless-to-digital initiatives within manufacturing environments.

• Support validation activities for computerized systems used across manufacturing and quality operations.
• Partner with Operations, Quality, Engineering, Manufacturing Technology, and IT stakeholders.
• Author and maintain validation plans, risk assessments, protocols, test scripts, traceability matrices, and validation reports.
• Support Data Integrity and 21 CFR Part 11 compliance activities.
• Participate in digital transformation initiatives focused on paper-based to electronic process conversion.
• Coordinate testing efforts and support issue resolution activities.
• Support change controls, deviations, CAPAs, and system lifecycle management.
• Drive communication and alignment across cross-functional project teams.

• 5+ years of CSV, validation engineering, quality systems, or related experience.
• Experience with in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Working knowledge of Computer Systems Validation (CSV), Data Integrity (DI), GMP requirements, and 21 CFR Part 11.
• Strong stakeholder communication and relationship management skills.
• Ability to effectively communicate with both technical and business audiences.

• Biotechnology manufacturing experience.
• Experience supporting paperless manufacturing initiatives.
• Hands‑on experience with MES, Tulip, Lab Vantage, MODA, Empower, Veeva, or similar GMP applications.
• Experience with automated testing and validation tools.
• Experience using Service Now, Track Wise, or ALM.
• Familiarity with GAMP 5 methodologies.
• Engineering commissioning, qualification, or startup experience.

• Began their career within Quality, Manufacturing Technology, Validation, Engineering, or another technical manufacturing function.
• Understands both the operational and compliance aspects of regulated manufacturing environments.
• Can confidently engage stakeholders ranging from manufacturing floor personnel to project and site leadership.
• Enjoys solving problems, driving alignment, and supporting modernization efforts across manufacturing operations.

• Brooksource Technology & Engineering Services connects engineering, manufacturing, and technology professionals with industry‑leading organizations executing critical operational and digital transformation initiatives.

Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP).

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.