CSA Validation SME (Hybrid in NJ)

Required Location: Hybrid/ Long Island City 3 days a week.

Job Description:

The CSA Validation SME is a key stakeholder in the 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
Demonstrated Competencies:
Technical Competency Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials
Time Management Able to follow strict deadlines, prioritize tasks, and work well under pressure
Analytical Skills Identifies, researches, and demonstrates logical reasoning to communicate critical information
Agility Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines
Strong written and verbal communication skills
Strong ability to communicate with other COE team members
Strong analytical and problem-solving abilities
Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality
Adept at solution development and project scoping
Effectively collaborate with peers, cross-functional teams, and departments
Strong technical background is preferred