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16 days old

Validation Engineer

Kelly Services
Bothell, WA 98021
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a **Validation Engineer** at a prestigious Fortune 500 company working in **Bothell, WA.**



This is a 12-month temporary position at 40 hours per week.



**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the submit now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( keig126@kellyservices.com ) however your resume must be received via the submit now button included within.



**Description:**



The Computer Systems / Delta V Validation Engineer role will enable GMP production to occur in a manner that assures equipment and processes are occurring as designed and in accordance to predefined acceptance criteria and testing policies. The candidate should be familiar with IT and validation principles. The Delta V Validation Engineer will work collaboratively with various system owners and quality groups to coordinate and execute validation activities; contributions will enable GMP manufacturing to occur in a manner that assures a high level of product quality to deliver cellular immunotherapies to our patients and customers.


**Job Description:**

o Collaborate with system owners and quality groups to coordinate and execute validation activities

o Engage with laboratory equipment vendors to implement instrument software packages

o Identify computer systems controls to comply with local policies for data integrity and Part 11 compliance

o Review and contribute to governing policies related to equipment qualification

o Maintain qualification/validation documentation (protocols, reports, schedule) in compliance with policy

o Facilitate both regularly scheduled and change-based requalification testing

o Develop, execute and summarize equipment qualification testing protocols and reports

o Develop documentation of requirements and specifications based on intended use (e.g. user requirements specifications, configuration specifications, etc.)

o Provide support and training to validation and system owner groups as needed to facilitate validation activities


**Basic Qualifications:**

o BS in engineering, computer science or equivalent scientific discipline + 3 years relevant work experience; or MS engineering, computer science or equivalent scientific discipline

o 1+ years of validation or IT experience

o Programming experience

o Excellent technical writing skills

o Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

Preferred Qualifications:

o Familiarity configuring software, Windows operating systems and network drives.

o Customer service experience

o Quality or validation experience in biotech, computer science or related field

o Strong technical understanding of biopharmaceutical systems, materials and equipment

o Experience in laboratory operations and basic understanding of analytical techniques

o Highly preferred intermediate knowledge of Waterfall and other SDLC methodologies

o Working knowledge of the cGMP regulations and concepts

o Familiarity with analytical equipment and validation methodologies




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



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




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Posted: 2019-11-01 Expires: 2019-12-02

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Validation Engineer

Kelly Services
Bothell, WA 98021

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