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
Northrop Grumman
Morrisville, North Carolina

Be a part of our mission! Northrop Grumman Space Systems (NGSP) seeks to find a Systems (Test) Engineer in the Payload and Ground Systems Division Engineering organization supporting the Integrated National Systems (INS) Business Unit (BU) to support a Ground program. The Payload and Ground Systems,...

Promoted
FHI 360
Durham, North Carolina

Collaborates with functional area managers to determine needs and expectations to create and finalize project deliverables. Identifies and resolves project issues and implements improvement plans to ensure project stays on schedule and within budget. Manages project budget and determines appropriate...

Promoted
Cisco Systems, Inc.
Raleigh, North Carolina

The Cisco Distributed System Engineering (DSE) group is at the forefront of developing products that power the largest networks in the world. This team builds products by harnessing the potential of open-source technologies while pushing the boundaries on Systems and Silicon Architecture. They are d...

Promoted
VirtualVocations
Durham, North Carolina

A company is looking for a Data Investigations Analyst to enhance trust and mitigate risks on its platform. ...

Promoted
RTI International
Durham, North Carolina

The Technology Practice Area within RTIs Social, Statistical, and Environmental Sciences (SSES) unit is seeking a Research Information Security Compliance Specialist. The candidate, under limited supervision, will be responsible for supporting the IT Security and Compliance Program; write, edit and ...

Promoted
Barrington James
NC, United States

We are seeking an experienced Quality Assurance Reviewer with a strong background in both biologics and small molecules to join our team. Collaborate with manufacturing, quality control, and regulatory teams to resolve quality issues and discrepancies in production records. Minimum of 3-5 years of e...

Promoted
Moorecroft Systems
Raleigh, North Carolina

Moorecroft is seeking to hire a Senior Software Engineer to build and innovate media and digital products, particularly enhancing streaming and digital platforms. ...

Promoted
AISIN North Carolina Corporation
Durham, North Carolina

The Supplier Quality Engineer will support and investigate supplied parts related quality problems and manufacturing difficulties. Quality Assurance or engineering role, experience with a focus on supplied parts quality and a minimum of 2 years in a fast-paced, high-volume manufacturing environment ...