Tech-Nique Partners
CSA Validation Subject Matter Expert (SME)
Tech-Nique Partners, Long Island City, New York, United States, 11101
Title:
CSA Validation Subject Matter Expert (SME) Work type:
Contract to hire Pay:
W2 only Travel: Hybrid onsite (3x per week) Location:
Long Island City, Queens NO THIRD PARTIES! Must Have: Extensive experience in the Medical, Pharmaceutical, or Regulatory Compliance industries. Strong CSA (Computer Software Assurance) experience; this role is a true SME function. Excellent communication, leadership, and collaboration skills. Positive, professional attitude; ability to work effectively with cross-functional teams. Agile experience/knowledge highly preferred. Role Overview: The
CSA Validation SME
plays a key role in the CSA Center of Excellence (COE). The primary responsibility is to ensure the integrity and compliance of CSA projects, with a strong focus on risk assessment and regulatory/data integrity requirements. This role serves as a critical bridge between COE leadership and protocol authors/testers, ensuring that validation projects align with R&D, GSC, and IT policies. Responsibilities: Provide expertise and guidance on validation project risk and complexity. Maintain and promote validation best practices. Gather project information from system owners. Partner closely with Business Analysts. Ensure compliance with Good Documentation Practices (GDP). Support writing and reviewing of reports summarizing CSA validation execution. Collect and incorporate feedback from system owners. Draft and execute GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as needed. Draft, review, and execute additional validation documentation when required. Qualifications: Bachelors Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related field. 710+ years of progressive experience with Computer System Validation (CSV) and Computer Software Assurance (CSA). Strong knowledge of GAMP 5 and 21 CFR Part 11 standards. Previous experience in a GxP or life sciences industry is required. Technical competency in FDA regulations. Experience in generating, reviewing, and addressing CAPAs. Strong written and verbal communication skills. Proven collaboration and teamwork abilities. Self-directed with strong time management and organizational skills. Practical experience with Data Integrity and ALCOA+ is a plus.
CSA Validation Subject Matter Expert (SME) Work type:
Contract to hire Pay:
W2 only Travel: Hybrid onsite (3x per week) Location:
Long Island City, Queens NO THIRD PARTIES! Must Have: Extensive experience in the Medical, Pharmaceutical, or Regulatory Compliance industries. Strong CSA (Computer Software Assurance) experience; this role is a true SME function. Excellent communication, leadership, and collaboration skills. Positive, professional attitude; ability to work effectively with cross-functional teams. Agile experience/knowledge highly preferred. Role Overview: The
CSA Validation SME
plays a key role in the CSA Center of Excellence (COE). The primary responsibility is to ensure the integrity and compliance of CSA projects, with a strong focus on risk assessment and regulatory/data integrity requirements. This role serves as a critical bridge between COE leadership and protocol authors/testers, ensuring that validation projects align with R&D, GSC, and IT policies. Responsibilities: Provide expertise and guidance on validation project risk and complexity. Maintain and promote validation best practices. Gather project information from system owners. Partner closely with Business Analysts. Ensure compliance with Good Documentation Practices (GDP). Support writing and reviewing of reports summarizing CSA validation execution. Collect and incorporate feedback from system owners. Draft and execute GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as needed. Draft, review, and execute additional validation documentation when required. Qualifications: Bachelors Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related field. 710+ years of progressive experience with Computer System Validation (CSV) and Computer Software Assurance (CSA). Strong knowledge of GAMP 5 and 21 CFR Part 11 standards. Previous experience in a GxP or life sciences industry is required. Technical competency in FDA regulations. Experience in generating, reviewing, and addressing CAPAs. Strong written and verbal communication skills. Proven collaboration and teamwork abilities. Self-directed with strong time management and organizational skills. Practical experience with Data Integrity and ALCOA+ is a plus.