Senior Validation Specialist
Job Title:
Senior Validation SpecialistLocation:
Warren NJ
Responsibilities:
Performs validation document generation, program management, and protocol execution activities.
Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
Protocol execution and project activities.
Execute qualification activities with oversight.
Participate in department and site project teams.
Perform qualification activities according to site objectives and timelines.
Edit department SOPs and generate basic revisions as required.
Execute CAPA plans, risk assessments, investigations, and root cause analysis.
Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
Performs general administrative and organizational activities.
Management of time and work deliverables, regular interface and reporting to management.
Complete regulatory, site, and department training requirements on a timely basis.
Perform other tasks as assigned.
Experience/Minimum Requirements Bachelor s degree preferred, preferably in Science or Engineering.
8 years relevant work experience required.
An equivalent combination of education, experience and training may substitute.
Working understanding of validation concepts and requirements.
Intermediate written and verbal communication skills.
Knowledge of cGMP.
Knowledge of validation industry and regulatory requirements Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first.
Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.
Through a genuine commitment to people in everything we do.
We have developed refined processes and a stellar internal team to deliver talent quickly.
More importantly, we focus on building long-term relationships, not transactions.
Putting people first is just what we do well.
Recommended Skills Administration Certified Global Meeting Planner Change Control Communication Data Analysis Document Management Systems Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
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on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3s32t6f5z2gm3thmy8', 'ExternalApply-j3s32t6f5z2gm3thmy8'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
Senior Validation SpecialistLocation:
Warren NJ
Responsibilities:
Performs validation document generation, program management, and protocol execution activities.
Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
Protocol execution and project activities.
Execute qualification activities with oversight.
Participate in department and site project teams.
Perform qualification activities according to site objectives and timelines.
Edit department SOPs and generate basic revisions as required.
Execute CAPA plans, risk assessments, investigations, and root cause analysis.
Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
Performs general administrative and organizational activities.
Management of time and work deliverables, regular interface and reporting to management.
Complete regulatory, site, and department training requirements on a timely basis.
Perform other tasks as assigned.
Experience/Minimum Requirements Bachelor s degree preferred, preferably in Science or Engineering.
8 years relevant work experience required.
An equivalent combination of education, experience and training may substitute.
Working understanding of validation concepts and requirements.
Intermediate written and verbal communication skills.
Knowledge of cGMP.
Knowledge of validation industry and regulatory requirements Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first.
Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.
Through a genuine commitment to people in everything we do.
We have developed refined processes and a stellar internal team to deliver talent quickly.
More importantly, we focus on building long-term relationships, not transactions.
Putting people first is just what we do well.
Recommended Skills Administration Certified Global Meeting Planner Change Control Communication Data Analysis Document Management Systems 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=j3s32t6f5z2gm3thmy8', 'ExternalApply-j3s32t6f5z2gm3thmy8'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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