Kelly Services Process Validation Engineer in Gaithersburg, Maryland

Kelly Scientific Resources has a great Direct Hire opening for a Process Validation Engineer in Gaithersburg, MD for a leading provider of custom lentiviral vectors for pre-clinical and clinical applications. You will apply your process validation knowledge and development experience to identify design space and define process control ranges for viral vector production. You will draft characterization study protocols/reports and work with Development, Analytical, and pre-Clinical manufacturing Process Development team members to ensure a robust, scalable production process.

Your profile

  • B.S.(+6 yrs), M.S. (+4 yrs), or Ph.D. (+2 yrs) in life sciences or chemical engineering and late stage biopharm industry product development experience

  • In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

  • Demonstrated expertise in biologics process validation preferred

  • Knowledgeable in Quality-by-Design and previous experience incorporating QbD principles into product development

  • Experienced creating, reviewing, and updating FMEA risk assessment due to new processes or changes that potentially impact product

  • Experienced in one, or both, of the following areas:

  • Bioreactor based production of biologics incorporating batch, fed-batch, or perfusion modes

  • Purification methods that include Harvest clarification, chromatography, Tangential flow filtration (TFF, UF/DF)

  • Familiar with analytical methods used in the characterization of Lentiviral vectors (ELISA, Flow Cytometry, qPCR, ddPCR, Western-blot, HPLC, Nanoparticle analysis (NTA, FFF, TRPS, etc.)

  • Superb documentation, organizational, and technical writing skills, capable of providing summaries and reports with little direct oversight

  • Highly motivated, independent, detail-oriented team player. Good organization, initiative, and a collaborative attitude are essential

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 9,000

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 2017 was $5.4 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.