CSA Validation SME

Location: Astoria

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