Job Title: CSV Engineer LVL IV Job Location: Portsmouth, NH
Job Duration: 10 months on W2
Summary:
The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance.
The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions.
Specialist will be involved as the QA CSV representative during small and large-scale projects.
Job Description:
Perform all aspects of QMS process Change Control, Deviations, CAPAs
Execute all responsibilities as CSV project lead for complex projects
Oversee all CSV lifecycle activities
Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives
Mentor junior specialists
Revise and maintain CSV SOPs
Assess departments standing in the business and regulatory aspects
Function as CSV SME in Inspections and Audits
Perform other duties as assigned.
Requirements and Responsibilities:
Computer Systems Validation 5-10 years (Required)
Adherence to cGMPs is required at all times during the manufacture of drug products.
All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects and related actions.
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
Must comply with safety policies of the company and site
Skills:
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
Strong written and oral communication skills.
Strong organizational and time management skills
Education:
Bachelor s Degree in Computer Science / Software Engineering (required)
Language:
English (Required)
Numbers & Facts
Location
Portsmouth, NH
Skills
Change Controlunmatched
Change Requests/Ordersunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Computer Systemsunmatched
Corporate Policiesunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Drug Productsunmatched
English Languageunmatched
GMP (Good Manufacturing Practices)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Mentoringunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Quality Assuranceunmatched
Regulationsunmatched
Risk Analysisunmatched
Safety Complianceunmatched
Safety Processunmatched
Safety Trainingunmatched
Safety/Work Safetyunmatched
Software Engineeringunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Analysisunmatched
Team Lead/Managerunmatched
Test Plan/Scheduleunmatched
Test Scriptsunmatched
Time Managementunmatched
Writing Skillsunmatched
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