Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
No Travel Required
Skills
Validation Engineer
Analytical Skill
Auditing
Budget
Collaboration
Data Integrity
Documentation
IQ
Management
Manufacturing
OQ
PQ
Procurement
Quality Control
Regulatory Compliance
Risk Assessment
URS
Job Details
Title: Analytical Validation Specialist IV
Location: Portsmouth, NH
Long Term Oniste
- Lead validation activities for analytical equipment, including software updates, new installations, and decommissioning.
- Act as Subject Matter Expert (SME) for analytical systems across Quality Control, Manufacturing, and other departments.
- Plan and execute validation protocols (IQ/OQ/PQ) for equipment and system changes.
- Manage and maintain TW records, including Change Controls, CAPAs, and Deviations.
- Create and review documentation such as User Requirements Specifications (URS), Data Integrity Risk Assessments, and Audit Trail Assessments.
- Evaluate and interpret equipment manuals to develop appropriate validation plans.
- Oversee procurement, budget alignment, and installation of analytical equipment.
- Assume ownership of analytical instruments and ensure ongoing compliance and performance.
- Identify and resolve quality issues in collaboration with relevant stakeholders.
- Review, approve, and participate in Commissioning, Qualification, and Validation (CQV) documentation and risk assessments.
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.