Kelly Services Validation Specialist - Pharma Industry! in Dallas, Texas
Validation Specialist – Dallas, TX
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.
Bachelor’s 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 a plus
Ability to understand and interpret regulations
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 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 career—connect with us today.
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 2016 was $5.3 billion. Visit kellyservices.com 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm