CSA Validation Subject Matter Expert (SME)

Role: CSA Validation Subject Matter Expert (SME)

Location: Long Island City, NY 11101 (Need Local Candidates only)

Duration: Contrac to Hire

HYBRID - 2-3 days a week in Long Island City, NY location

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 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

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