CSA Validation SME

Global Business Ser. 4u; New York (NY); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Global Business Ser. 4u is seeking a CSA Validation SME in New York City, operating hybrid with local engagement in Long Island City. The role ensures CSA project integrity, assesses risk, and confirms compliance with regulatory and data integrity requirements.

The candidate should have extensive Medical/Pharma/GxP experience, strong communication and leadership, and familiarity with GDP, CAPAs, and 21 CFR Part 11; Agile experience is preferred.

Qualifications

• Bachelor's degree in CS/IT/Engineering or related field
• 7–10+ years in Computer System Validation/CS Assurance
• GAMP 5 and 21 CFR Part 11 knowledge
• Experience in a life sciences/GxP environment
• Strong communication and leadership with collaborative style
• Agile experience preferred

Responsibilities

• Provide insight on validation project risk and complexity
• Maintain validation best practices
• Collaborate with system owners to gather information
• Work with Business Analyst on a frequent basis
• Ensure GDP compliance in all activities
• Draft and review Reports (VSR, VP, TP, RA) as needed
• Collect feedback from System Owners on deliverables
• Prepare and execute validation documentation as required
• Draft, review, and execute other validation documents when necessary

Skills

CSA Validation

Regulatory Compliance

Communication

Leadership

Agile

Education

Bachelor's Degree (CS/IT/Engineering)

Job description

Long Island City, NY 11101 (Hybrid) Local Only

• CSA Validation SME
• 6 months +
• Long Island City, NY 11101 (Hybrid) Local Only

Must Have

• Extensive experience in the Medical, Pharma or Regulatory Compliance Industries
• Strong CSA experience as they will be acting as the SME
• Must have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work with
• Agile experience/knowledge is highly preferred.

The CSA Validation SME is a key stakeholder in the ELC CSA Center of Excellence (COE). The primary function of this role is to ensure the integrity of CSA projects, with an eye to assessing risk and ensuring integrity. Their responsibilities serve as a key conduit between the COE leadership and the protocol author(s) and tester(s). The CSA Validation SME will ensure validation projects meet regulatory and data integrity requirements, and they will confirm validation projects meet R&D/GSC/IT policies.

Responsibilities

• Provide insight and expertise on validation project risk and complexity
• Maintain validation best practices
• Gather project information from system owner(s)
• Collaborate with the Business Analyst on a frequent basis
• Maintain compliance with Good Documentation Practices (GDP)
• Aid in writing and reviewing of reports summarizing system CSA validation execution
• Collect feedback from System Owner(s) on deliverables
• Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary
• Draft, review, and execute other validation documents when necessary

Qualifications

• Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree
• 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance
• Aptitude in GAMP 5 and 21 CFR Part 11 standards
• Previous experience in a GxP industry or a life sciences industry is required
• Technical competency in FDA regulations
• Expertise in generating, reviewing, and addressing CAPAs
• Strong written and verbal communication skills
• Strong ability to collaborate with the team
• Ability to work self-directed in the timely completion of project deliverables
• Practical experience with Data Integrity and ALCOA+ is a plus