Kelly Services SE42 - Technical Writer - Scientific in Englewood, Colorado

Technical Writer - Scientific -$60-80K (Temp to HIre or for the right person Direct Hire)

Job Purpose and Function:

Responsible for routine and corrective cleaning of cleanroom equipment and performing operations in an ISO5 to ISO9 environment to produce drug product following approved Standard Operating Procedures (SOPs) related to these activities. Gowning and Personnel Protective Equipment (PPE) are required to perform job functions. Position will also have some additional responsibilities in the general areas of facilities and maintenance, warehousing, inventory management, and contractor management.

Primary Job Functions and Responsibilities:

  • Ability to don gowning in an aseptic manner and maintain qualification throughout employment.

  • Ability to read and perform approved Standard Operating Procedures (SOPs).

  • Maintain cleanliness of cleanroom equipment and associated areas.

  • Daily monitoring and checking of equipment/systems.

  • Assist Operations in the operation of processing equipment and executing production processes. Perform line clearance and batch preparation/reconciliation activities.

  • Monitors and completes documentation for actions performed per cGMP.

  • Perform minor preventative maintenance tasks.

  • Coordination of routine and non-routine contractors.

  • Assists Operations and QA in the receipt, approval and release of materials.

  • Obtain and stock all consumable supplies related to cleaning. This includes cleaning solutions, cleaning supplies and gowning supplies following facilities flows.

  • Manage supplies and inform purchasing on re-ordering of materials.

  • Monitors/tracks inventory and adjusts paperwork as needed.

  • Perform daily activities in the processing area following all relevant SOPs.

  • Performs other duties as necessary.

Key Skills Required:

Requires the ability to learn GMP processes and equipment. Cleanroom experience is preferred.

Understands aseptic processing and compliance requirements. Previous knowledge of FDA, GMPs, OSHA Safety, SOPs and other regulations is preferred.

Excellent documentation and organizations skills required.

Ability to troubleshoot and identify problem areas within facility and offer solutions to remedy situations.

Ability to do basic math and conversions.

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 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