Overview
On Site
Depends on Experience
Contract - W2
Contract - Independent
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.
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