CSA Validation SME

• 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