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Validation Engineer

Kelly Services

Durham, NC
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Validation Engineer

Jobid US41L8DV_BH1435270

Location: Durham, NC, 27722, USA

Description **Job Details:**

**Industry:** Biopharmaceutical

**Work Location:** Durham, NC

**Job Title:** Validation Engineer

**Duration:** 8 Months (Temporary/Contract)
**_Validation Engineer – Durham, NC_**

Kelly Services is currently seeking a **Validation Engineer** for one of our top clients in **Durham, NC** .


**Validation Engineer**
This position will be responsible for overseeing the development of a new analytical robot for inhaler testing.

Project Management, People Management, Problem Solving, Communication

• Act as the cross site Lead for the creation of the User Requirement Specification (URS).
• Arrange and lead workshops to accurately map, and where possible, simplify business workflows and translate them into unambiguous user requirements.
• Organize requirements in an optimal way, aspiring to create a state of the art URS i.e. covers all aspects of the future robot in a human friendly way.
• Liase with all supporting functions whose input is required for the creation of the URS e.g. Quality Assurance, IT and SHE.
• Secure that all work is performed according to the Quality Management Framework and cGMP standards.
• Liase with vendor to ensure design aligns with the URS.
• Manage SAT, FAT, PQ and IQ/OQ activities and documentation.
• Support the Business in reviewing URS responses from potential suppliers of the robot.
• Support the Project Manager with updating schedules, costs, and risks as needed.

**Minimum Requirements:**
Education and Experience, Functional & Business knowledge

• Degree in a relevant science or engineering discipline
• Minimum 5 years’ experience of leading work around development of URS documents related to automation set within a GxP regulated environment.
• Previous experience around automating analysis of inhalers is desirable.
• Knowledge of GAMP5 Requirements is desirable.

**Skills and Capabilities**
• Collaborative…
• Proven communication and organizational skills for global working
• Able to travel up to 50% time

Candidate must be open to travel to Sweden and France. Travel is non-negotiable. Analytical Automation experience is preferred as well.

**Why Kelly?**
As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group-rate insurance options available immediately upon hire*
**Apply Today!**

**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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