LL01-062824 Validation Specialist

Validation & Engineering Group
Raleigh, NC, US
Full-time

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following areas :

  • Process Equipment and Utilities IQ / OQ
  • Computer System Validation (CSV)
  • Experience with the qualification of several of the following equipment and processes :
  • HVAC, environmental monitoring, Laminar Flow Hoods, CIP / SIP skids, Freezers, Parts Washers, Autoclaves, Isolators, Vacuum Pumps, Debagger, Delidder, Syringe Filling Machines, Syringe Inspection, Peristaltic Pumps, Gas Monitoring, Filter Integrity Testers, VHP Generators, Material Transfer Isolators, Check Weighs, Portable Tanks, Oxygen Sensor, Heat Exchangers, PH Meter, TCU, Scales / Balances, Sterilization and decontamination processes with VHP generators, Automation Control Systems, BAS systems.
  • Able to work independently.

Qualifications :

  • Bachelor's Degree in Science or Engineering
  • Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in IOQs within direct process / manufacturing areas.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.

e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).

  • Kneat experience valuable.
  • 13 days ago
Related jobs
Promoted
Validation & Engineering Group
Raleigh, North Carolina

Validation & Engineering Group, Inc. V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other ...

Validation & Engineering Group, Inc
Raleigh, North Carolina

Validation & Engineering Group, Inc. V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services...

Promoted
NetApp
Morrisville, North Carolina

Member of a software engineering team involved in development & design of the features related to AI/ML for NetApp’s flagship storage operating ONTAP. Software engineers focus on enhancements to existing products as well as new product development. This is a mid-level technical position that require...

Promoted
Standard Technology
Camp Lejeune, NC, US

Medical Coding Compliance Specialist. At least one of the following recognized professional coding certifications from AHIMA and or AAPC is required: Registered Health Information Technician (RHIT); Registered Health Information Administrator (RHIA); Certified Professional Medical Auditor (CPMA); Ce...

Promoted
bioMerieux Inc.
Durham, North Carolina

Manufacturing Compliance Specialist - Weekend Day Shift. The Manufacturing Compliance Specialist will focus on Right First Time (RFT) initiatives. Review of manufacturing documentation for compliance to GDP and CPP prior to submission to QA. Track training activities and curriculums to ensure compli...

Promoted
Cisco Systems, Inc.
Durham, North Carolina

Currently enrolled in a full-time undergraduate program in Computer Science, Software Engineering, Computer Engineering, Electrical. Engineering, Information Technology, Supply Chain, Customer Experience, Security and Trust, etc. Our software engineers are the gurus behind the scenes. ...

Promoted
VirtualVocations
Durham, North Carolina

A company is looking for a Senior Financial Data Analyst to drive profitability through data-driven analysis. ...

Promoted
EdEx - Education Recruitment
Raleigh, North Carolina
Remote

Job Title: QA Engineer (Remote - NYC). We offer a fully remote role, but we're seeking a QA Engineer with a connection to the NYC area. ...

Promoted
Gpac
Durham, North Carolina

Related titles: HVAC Project Manager, Mechanical Project Manager, HVAC Estimator, Project Supervisor, Senior Project Manager, Construction Project Manager, MEP Project Manager, HVAC Superintendent, Mechanical Estimator, Project Engineer, Field Project Manager, Site Supervisor, HVAC Construction Mana...

Promoted
Randstad Life Sciences US
Durham, North Carolina

The Validation Engineer 1- Qualification will coordinate, execute tasks, and provide technical engineering support for a variety of assets. Validation experience on the equipment side, less with computer systems (CSV). They will primarily interact with operations, development scientists, and softwar...