Validation Engineer

Portsmouth, NH, US • Posted 2 days ago • Updated 4 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Job Details

Skills

  • Team Leadership
  • Training
  • Regulatory Compliance
  • Test Scripts
  • GMP
  • Documentation
  • Quality Assurance
  • QMS
  • Change Control
  • Project Management
  • Manufacturing Engineering
  • Mentorship
  • Auditing
  • Computer Science
  • Software Engineering
  • GAMP
  • Computerized System Validation
  • Communication
  • Management

Summary

Job Description:
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.
Responsibilities:
  • 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:
  • Bachelor's Degree (Computer Science / Software Engineering).
  • Advanced - 5-10 years.
  • 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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 11d4f660811ab016051cbe5005904861
  • Posted 2 days ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Portsmouth, New Hampshire

4d ago

Easy Apply

Contract

Depends on Experience

Portsmouth, New Hampshire

Today

Full-time

Portsmouth, New Hampshire

Today

Full-time

Woburn, Massachusetts

Today

Full-time

Search all similar jobs