Computer Systems Validation (CSV) Analyst

Brooksource Technology & Engineering Services
Supporting a Leading Pharmaceutical Manufacturing Partner

Location: Concord, NC (On-Site)
Duration: 12-Month Contract
Pay Rate: Up to $90/hour

About the Opportunity

· 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.

What You Will Be Doing

· 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.

Required Qualifications

· 5+ years of CSV, validation engineering, quality systems, or related experience.

· Experience within 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.

· Experience creating validation lifecycle documentation.

· Ability to effectively communicate with both technical and business audiences.

Preferred Qualifications

· Biotechnology manufacturing experience.

· Biotech digital transformation experience.

· Experience supporting paperless manufacturing initiatives.

· Hands-on experience with MES, Tulip, LabVantage, MODA, Empower, Veeva, or similar GMP applications.

· Experience with automated testing and validation tools.

· Experience using ServiceNow, TrackWise, or ALM.

· Familiarity with GAMP 5 methodologies.

· Engineering commissioning, qualification, or startup experience.

Ideal Candidate Profile

· 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.

About Brooksource

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

Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

EEO: We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Benefits & Perks: 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) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer: 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.

Pay: $70.00 - $90.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person