CSA DATA Validation Subject Matter Expert (SME) Hybrid, Contract to Hire (Fortune 250)
Title:
CSA Validation Subject Matter Expert (SME)High Priority, Feb StartLocation:
Hybrid onsite at LIC (2-3 days per week), must be localMax Pay Rate:
$75 - $90/hrW2 OnlyPossible contract to hire opportunity for the right candidate - based on business needMust be able to convert Must Have:
Extensive experience in the Medical, Pharma or Regulatory Compliance IndustriesStrong CSA experience as they will be acting as the SMEMust have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work withAgile experience/knowledge highly preferred. 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:
o Provide insight and expertise on validation project risk and complexityo Maintain validation best practiceso Gather project information from system owner(s)o Collaborate with the Business Analyst on a frequent basiso Maintain compliance with Good Documentation Practices (GDP)o Aid in writing and reviewing of reports summarizing system CSA validation executiono Collect feedback from System Owner(s) on deliverableso Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessaryo Draft, review, and execute other validation documents when necessary
Qualifications:
o Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degreeo 7-10
years of successful, progressive experience with Computer System Validation and Computer Software Assuranceo Aptitude in GAMP 5 and 21 CFR Part 11 standardso Previous experience in a GxP industry or a life sciences industry is requiredo Technical competency in FDA regulationso Expertise in generating, reviewing, and addressing CAPAso Strong written and verbal communication skillso Strong ability to collaborate with the teamo Ability to work self-directed in the timely completion of project deliverableso Practical experience with Data Integrity and ALCOA
is a plus Demonstrated Competencies:
o Technical Competency - Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materialso Time Management - Able to follow strict deadlines, prioritize tasks, and work well under pressureo Analytical Skills - Identifies, researches, and demonstrates logical reasoning to communicate critical informationo Agility - Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelineso Strong written and verbal communication skillso Strong ability to communicate with other COE team memberso Strong analytical and problem-solving abilitieso Understands the purpose of CSA, is passionate about customer safety, data integrity, and product qualityo Adept at solution development and project scopingo Effectively collaborate with peers, cross-functional teams, and departmentso Strong technical background is preferred CSA DATA Validation Subject Matter Expert (SME) Hybrid, Contract to Hire (Fortune 250) Recommended Skills Agile Methodology Agility Analytical Biomedical Engineering Business Requirements Chemical Engineering Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3m8b269rt831l94d73', 'ExternalApply-j3m8b269rt831l94d73'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
CSA Validation Subject Matter Expert (SME)High Priority, Feb StartLocation:
Hybrid onsite at LIC (2-3 days per week), must be localMax Pay Rate:
$75 - $90/hrW2 OnlyPossible contract to hire opportunity for the right candidate - based on business needMust be able to convert Must Have:
Extensive experience in the Medical, Pharma or Regulatory Compliance IndustriesStrong CSA experience as they will be acting as the SMEMust have good communication and leadership skills, collaboration skills, must have a positive attitude and be easy to work withAgile experience/knowledge highly preferred. 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:
o Provide insight and expertise on validation project risk and complexityo Maintain validation best practiceso Gather project information from system owner(s)o Collaborate with the Business Analyst on a frequent basiso Maintain compliance with Good Documentation Practices (GDP)o Aid in writing and reviewing of reports summarizing system CSA validation executiono Collect feedback from System Owner(s) on deliverableso Draft and execute of GxP Assessment, Risk Assessment (RA), Validation Plan (VP), Test Plan (TP), and Validation Summary Report (VSR) as necessaryo Draft, review, and execute other validation documents when necessary
Qualifications:
o Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degreeo 7-10
years of successful, progressive experience with Computer System Validation and Computer Software Assuranceo Aptitude in GAMP 5 and 21 CFR Part 11 standardso Previous experience in a GxP industry or a life sciences industry is requiredo Technical competency in FDA regulationso Expertise in generating, reviewing, and addressing CAPAso Strong written and verbal communication skillso Strong ability to collaborate with the teamo Ability to work self-directed in the timely completion of project deliverableso Practical experience with Data Integrity and ALCOA
is a plus Demonstrated Competencies:
o Technical Competency - Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materialso Time Management - Able to follow strict deadlines, prioritize tasks, and work well under pressureo Analytical Skills - Identifies, researches, and demonstrates logical reasoning to communicate critical informationo Agility - Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelineso Strong written and verbal communication skillso Strong ability to communicate with other COE team memberso Strong analytical and problem-solving abilitieso Understands the purpose of CSA, is passionate about customer safety, data integrity, and product qualityo Adept at solution development and project scopingo Effectively collaborate with peers, cross-functional teams, and departmentso Strong technical background is preferred CSA DATA Validation Subject Matter Expert (SME) Hybrid, Contract to Hire (Fortune 250) Recommended Skills Agile Methodology Agility Analytical Biomedical Engineering Business Requirements Chemical Engineering Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3m8b269rt831l94d73', 'ExternalApply-j3m8b269rt831l94d73'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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