Global Technical Talent
CSA Validation Subject Matter Expert (SME)
Global Technical Talent, Long Island City, New York, United States, 11101
Primary Job Title:
CSA Validation Subject Matter Expert (SME)
Alternate/Related Job Titles: Computer Software Assurance Consultant CSV/CSA Specialist Validation SME - Life Sciences GxP Compliance Analyst Regulatory Validation Lead
Location: Long Island City, NY
Onsite Flexibility: Hybrid (3 days onsite)
Contract Details: Position Type:
Contract Contract Duration:
6.5 months Start:
09/18/2025 End:
03/31/2026 Pay Rate:
$90/hr Job Summary: We are seeking a
CSA Validation Subject Matter Expert (SME)
to join a high-impact team within the CSA Center of Excellence (COE). This role is responsible for
ensuring regulatory compliance and integrity
in CSA validation projects within the medical, pharmaceutical, and regulatory industries. The SME will serve as a liaison between COE leadership and validation protocol authors/testers, helping maintain documentation standards and ensuring all deliverables align with GxP, FDA, and internal policy frameworks.
Key Responsibilities:
Provide risk and complexity assessments for validation projects Maintain validation best practices and Good Documentation Practices (GDP) Collaborate closely with Business Analysts and system owners Support documentation such as GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Summary Reports Review and execute CSA documentation and validation deliverables Assist in reporting, testing summaries, and regulatory documentation Gather and integrate feedback from stakeholders Ensure compliance with data integrity and ALCOA+ principles Required Experience:
7-10+ years in Computer System Validation or Computer Software Assurance Experience in GxP or life sciences environments Proven technical competency in FDA regulations Bachelor's in Computer Science, Biomedical/Chemical Engineering, or related field Nice-to-Have Experience:
Agile project experience Familiarity with ALCOA+ principles Experience addressing and resolving CAPAs Practical exposure to data integrity methodologies Required Skills:
Strong CSA validation knowledge Expertise with GAMP 5 and 21 CFR Part 11 Excellent written and verbal communication Ability to work independently and meet deadlines Strong collaboration and team engagement Preferred Skills:
Project scoping and solution development Time management and multitasking under tight timelines Analytical problem-solving and decision-making skills Additional Skills:
Customer-focused mindset centered on safety and compliance Adaptability to shifting priorities in a regulated environment Strong technical background beneficial Benefits:
Medical, Vision, and Dental Insurance Plans 401k Retirement Fund
About the Client: Leading global beauty company offering skincare, makeup, fragrance, and hair care products. Committed to innovation, sustainability, and corporate citizenship. Fosters a diverse and inclusive work environment.
About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number:
25-26222 #LI-GTT #LI-Hybrid
Alternate/Related Job Titles: Computer Software Assurance Consultant CSV/CSA Specialist Validation SME - Life Sciences GxP Compliance Analyst Regulatory Validation Lead
Location: Long Island City, NY
Onsite Flexibility: Hybrid (3 days onsite)
Contract Details: Position Type:
Contract Contract Duration:
6.5 months Start:
09/18/2025 End:
03/31/2026 Pay Rate:
$90/hr Job Summary: We are seeking a
CSA Validation Subject Matter Expert (SME)
to join a high-impact team within the CSA Center of Excellence (COE). This role is responsible for
ensuring regulatory compliance and integrity
in CSA validation projects within the medical, pharmaceutical, and regulatory industries. The SME will serve as a liaison between COE leadership and validation protocol authors/testers, helping maintain documentation standards and ensuring all deliverables align with GxP, FDA, and internal policy frameworks.
Key Responsibilities:
Provide risk and complexity assessments for validation projects Maintain validation best practices and Good Documentation Practices (GDP) Collaborate closely with Business Analysts and system owners Support documentation such as GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Summary Reports Review and execute CSA documentation and validation deliverables Assist in reporting, testing summaries, and regulatory documentation Gather and integrate feedback from stakeholders Ensure compliance with data integrity and ALCOA+ principles Required Experience:
7-10+ years in Computer System Validation or Computer Software Assurance Experience in GxP or life sciences environments Proven technical competency in FDA regulations Bachelor's in Computer Science, Biomedical/Chemical Engineering, or related field Nice-to-Have Experience:
Agile project experience Familiarity with ALCOA+ principles Experience addressing and resolving CAPAs Practical exposure to data integrity methodologies Required Skills:
Strong CSA validation knowledge Expertise with GAMP 5 and 21 CFR Part 11 Excellent written and verbal communication Ability to work independently and meet deadlines Strong collaboration and team engagement Preferred Skills:
Project scoping and solution development Time management and multitasking under tight timelines Analytical problem-solving and decision-making skills Additional Skills:
Customer-focused mindset centered on safety and compliance Adaptability to shifting priorities in a regulated environment Strong technical background beneficial Benefits:
Medical, Vision, and Dental Insurance Plans 401k Retirement Fund
About the Client: Leading global beauty company offering skincare, makeup, fragrance, and hair care products. Committed to innovation, sustainability, and corporate citizenship. Fosters a diverse and inclusive work environment.
About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!
Job Number:
25-26222 #LI-GTT #LI-Hybrid