Role & seniority: CSA Validation Subject Matter Expert (SME); senior/lead-level contractor leading validation activities within the CSA COE; contract-to-hire, W2 only.

Stack/tools: Computer Software Assurance (CSA) and Computer System Validation (CSV); GAMP 5; 21 CFR Part 11; Good Documentation Practices (GDP); GxP; CAPA; validation artifacts (RA, VP, TP, VSR); ALCOA+/Data Integrity.

Top 3 responsibilities

Provide expertise on validation risk, complexity, and governance; maintain validation best practices.
Ensure regulatory/data integrity alignment; draft and review GxP documents (RA, VP, TP, VSR) and associated reports; support system-owner reviews.
Bridge COE leadership with protocol authors/testers; collaborate with Business Analysts and cross-functional teams; ensure GDP/compliance in all validation activities.

Must-have skills

Extensive bioscience/medical/pharma/regulatory compliance background.
Strong CSA/CSV SME with 7–10+ years in related fields.
Proficiency in GAMP 5 and 21 CFR Part 11; FDA regulatory knowledge; CAPA experience.
Excellent written/verbal communication, leadership, collaboration; self-directed with strong time management.
Agile experience preferred.
Nice-to-haves: Data Integrity/ALCOA+ experience; proven cross-functional collaboration; additional regulatory/industry certifications.
Location & work type: Long Island City, Queens; hybrid onsite (3x per week); contract-to-hire; W2 only; no third parties.

Full Description

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

Bachelor’s Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related field.
7–10+ 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.