5 days old

Validation Specialist

Kelly Services
Dallas, TX 75219
**Validation Specialist Dallas, TX 75238**

Kelly Scientific Resources is currently seeking a Validation Specialist for one of our top pharmaceutical clients in Dallas, TX.

As a Validation Specialist placed with Kelly Scientific Resources, you will be responsible for leading and managing the Validation Program throughout the plant, and coordinate validation activities among different departments.

**Additional Job Responsibilities:**

+ Perform cleaning validation of manufacturing equipment used for products.

+ Prepare equipment validation protocols (Installation, Operational, and Performance), conduct execution of protocol and write summary reports.

+ Prepare process and cleaning validation protocols, conduct execution of protocol and write summary report after the completion.

+ Assist in external regulatory audits.

+ Develop Validation Master Plan for requalification or prospective validation.

+ Perform gap analysis against global guideline, identify risk and develop corrective actions to close the gaps.

+ Assist in external regulatory audits (FDA, ISO, NAFDAC) and internal audits to ensure cGMP and 21CFR 211 compliance.

+ Co-ordinate and communicate with Engineering, Production, Planning & Quality teams on different validation activities and their responsibilities.

+ Develop, track, and communicate overall validation program through monthly KPIs.

+ Generate different types of protocol for aseptic validation, execute and write technical report of completed qualification.

+ Review and approve/concur on documentation that pertains to Quality and Manufacturing systems and processes (validation, engineering projects, and Product/Process changes).

+ Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.

**Job Requirements:**

+ Bachelors degree with concentration in any science or engineering

+ 3 to 5 years of work experience in similar role

+ Experience in pharmaceutical, manufacturing or biotechnology industries, including experience with aseptic processing is preferred

+ ASQ Certified Quality Engineer desired

+ Excellent computer skills

+ Familiarity with Ensur is a plus

+ Ability to understand and interpret regulations

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

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**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. at
Posted: 2020-01-13 Expires: 2020-02-13

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Validation Specialist

Kelly Services
Dallas, TX 75219

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