24 days old

Validation Engineer CQV

Kelly Services
Morrisville, NC 27560
Kelly Engineering, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a **Validation Engineer CQV** for a long-term engagement at one of our Global Pharmaceutical clients in Morrisville, NC. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. All KellyOCG employees receive annual performance reviews.

**Validation Engineer CQV**

**Several year contract with benefits**

DP CQV lead: Part of the CQV team in the Galaxy project and responsible for CQV deliverablesreporting to work package owner

DP CQV lead: Overall Drug Product and Finished Goods experience in Formulation, Filling and Packaging (including Serialization) and integration with utilities systems

5+ years experience in team Lead/Management position

Support recruitment of process team members including support functions (e.g., Doc Control, Turnover, Scheduling, Vendor Management etc.)

Liaise with various project departments (Design, QA, Engineering, Mfg. etc.) on project related queries

Delivery of the project at each stage Design, Document Generation, FAT, Mechanical Completion, Set to Work, Pre-Safety Start up Reviews, Commissioning, Qualification, and full handover to Operations.

Securing high quality and on time deliverables

Perform relevant tracking in place for CQV deliverables, both documentation readiness and field execution of protocols and test scripts.

Act as Project SME for relevant CQV processes, including ASTM E2500, which will be utilized for CQV document creation and field execution

Create and manage all documentation produced for the Project, including Plans, SOPs, Strategies, DQ, QRA, RTM, FAT, RV, SAT, IOC, IOQ and all supporting Final Reports

Manage execution of all testing from FAT through to IOQ

Prepares & presents project status & targets

Coordinated with end user and other functions on all work package deliverables in the Galaxy project

**Why Kelly** **** **?**

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook ( , LinkedIn ( and Twitter ( .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (
Posted: 2021-09-24 Expires: 2021-10-25

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Validation Engineer CQV

Kelly Services
Morrisville, NC 27560

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