Overview
Equipment Qualification Engineer Jobs in North Carolina, United States at United Pharma
Title: Equipment Qualification Engineer
Company: United Pharma
Location: North Carolina, United States
Tittle: Equipment Qualification Engineers
Equipment Qualification Engineers – Sterile Filling Expansion Project
We are seeking experienced Equipment Qualification Engineers to support commissioning, qualification, and validation (CQV) activities for manufacturing equipment as part of a major sterile filling expansion project.
Equipment Scope
The role will support qualification of the following GMP manufacturing equipment:
- Syringe Filling Isolators
- Vial Filling Isolators
- Formulation Skids
- Clean-in-Place (CIP) Systems
- Steam-in-Place (SIP) Systems
- Pre-Use Post Sterilization Integrity Testing (PUPSIT) Systems
- Autoclaves
- Parts Washers
- Material Transfer Isolators
- Container Closure Integrity Testing (CCIT) Systems
- Automated Visual Inspection Systems
- Serialization Units
- Ring Labelers
- Thaw Systems
Key Responsibilities
- Author, review, and execute IQ, OQ, and PQ protocols for GMP manufacturing equipment.
- Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Provide commissioning, startup, and qualification support during equipment installation and deployment.
- Execute qualification testing, accurately document results, and ensure compliance with GMP requirements.
- Investigate, document, and manage deviations, protocol discrepancies, and qualification exceptions.
- Prepare and finalize qualification summary reports.
- Collaborate closely with Engineering, Manufacturing, Validation, and Quality teams throughout commissioning and startup activities.
Required Qualifications
- Minimum of 5 years of commissioning, qualification, and validation (CQV) or equipment qualification experience within the pharmaceutical industry.
- Hands-on experience qualifying GMP manufacturing equipment.
- Strong understanding of pharmaceutical manufacturing processes and GMP requirements.
- Excellent technical writing and documentation skills.
Preferred Qualifications
- Experience qualifying aseptic filling lines.
- Hands-on experience with isolator systems.
- Background in sterile pharmaceutical manufacturing environments.
