Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: CSA Validation SME/ GXP/ GAMP 5.
United States Jobs Expertini

Urgent! CSA Validation SME/ GXP/ GAMP 5 Job Opening In Long Island – Now Hiring Katalyst HealthCares & Life Sciences

CSA Validation SME/ GXP/ GAMP 5



Job description


Job Description:

  • We need: A senior CSA (Computer Software Assurance) SME with GAMP , GxP and CFR Part standards.

    Candidates need to have previous experience in the GxP industry, or a life sciences industry is required as well as technical competency in FDA regulations.

    They must draft and execute the GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessary.

    Candidates must have expertise in generating, reviewing, and addressing CAPAs as well as experience with Data Integrity and ALCOA+ is a plus.

  • 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 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.

  • Requirements:
  • Bachelor's degree in computer science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree.

  • -+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance.

  • Aptitude in GAMP and CFR Part standards.

  • Previous experience in the 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.



  • Required Skill Profession

    Computer Occupations



    Your Complete Job Search Toolkit

    ✨ Smart • Intelligent • Private • Secure

    Start Using Our Tools

    Join thousands of professionals who've advanced their careers with our platform

    Rate or Report This Job
    If you feel this job is inaccurate or spam kindly report to us using below form.
    Please Note: This is NOT a job application form.


      Unlock Your CSA Validation Potential: Insight & Career Growth Guide


    • Real-time CSA Validation Jobs Trends in Long Island, United States (Graphical Representation)

      Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for CSA Validation in Long Island, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 2246 jobs in United States and 3 jobs in Long Island. This comprehensive analysis highlights market share and opportunities for professionals in CSA Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

    • Are You Looking for CSA Validation SME/ GXP/ GAMP 5 Job?

      Great news! is currently hiring and seeking a CSA Validation SME/ GXP/ GAMP 5 to join their team. Feel free to download the job details.

      Wait no longer! Are you also interested in exploring similar jobs? Search now: .

    • The Work Culture

      An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Katalyst HealthCares & Life Sciences adheres to the cultural norms as outlined by Expertini.

      The fundamental ethical values are:
      • 1. Independence
      • 2. Loyalty
      • 3. Impartiality
      • 4. Integrity
      • 5. Accountability
      • 6. Respect for human rights
      • 7. Obeying United States laws and regulations
    • What Is the Average Salary Range for CSA Validation SME/ GXP/ GAMP 5 Positions?

      The average salary range for a varies, but the pay scale is rated "Standard" in Long Island. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    • What Are the Key Qualifications for CSA Validation SME/ GXP/ GAMP 5?

      Key qualifications for CSA Validation SME/ GXP/ GAMP 5 typically include Computer Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

    • How Can I Improve My Chances of Getting Hired for CSA Validation SME/ GXP/ GAMP 5?

      To improve your chances of getting hired for CSA Validation SME/ GXP/ GAMP 5, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

    • Interview Tips for CSA Validation SME/ GXP/ GAMP 5 Job Success
      Katalyst HealthCares & Life Sciences interview tips for CSA Validation SME/ GXP/ GAMP 5

      Here are some tips to help you prepare for and ace your job interview:

      Before the Interview:
      • Research: Learn about the Katalyst HealthCares & Life Sciences's mission, values, products, and the specific job requirements and get further information about
      • Other Openings
      • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
      • Dress Professionally: Choose attire appropriate for the company culture.
      • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
      • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
      During the Interview:
      • Be Punctual: Arrive on time to demonstrate professionalism and respect.
      • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
      • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
      • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
      • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
      • Follow Up: Send a thank-you email to the interviewer within 24 hours.
      Additional Tips:
      • Be Yourself: Let your personality shine through while maintaining professionalism.
      • Be Honest: Don't exaggerate your skills or experience.
      • Be Positive: Focus on your strengths and accomplishments.
      • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
      • Turn Off Phone: Avoid distractions during the interview.
      Final Thought:

      To prepare for your CSA Validation SME/ GXP/ GAMP 5 interview at Katalyst HealthCares & Life Sciences, research the company, understand the job requirements, and practice common interview questions.

      Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Katalyst HealthCares & Life Sciences's products or services and be prepared to discuss how you can contribute to their success.

      By following these tips, you can increase your chances of making a positive impression and landing the job!

    • How to Set Up Job Alerts for CSA Validation SME/ GXP/ GAMP 5 Positions

      Setting up job alerts for CSA Validation SME/ GXP/ GAMP 5 is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!