Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Clinical Manufacturing Engineer at a prestigious Fortune 500® company working in Fremont.
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 Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.
Job Title: Clinical Manufacturing Engineer
The engineer will maintain, qualify, and troubleshoot upstream (cell culture) and downstream (purification) process equipment in the single-use multi-product GMP manufacturing facility (Flextrain). The position will maintain existing equipment, evaluate new equipment for launch and commercial supply readiness as well as evaluate compliance with data integrity standards. The position will also drive trouble shooting and continuous improvement activities/projects.
The position is responsible for planning and executing projects in a cross-functional project organization in support of New Product Introduction and technology transfer of both internal projects within BI and external projects from clients (Contract Manufacturing Business).
Responsibilities include but are not limited to:
- Maintain existing equipment (e.g. Single Use Bioreactors, AKTAready chromatography skid, Metabolite Analyzer, Blood Gas Analyzer, Cell Counter, UV Spectrophotometer, etc.)
- Execute qualification and validation for new equipment
- Become Subject Matter Expert on analytical and process equipment
- Troubleshoot equipment issues on the floor
- Evaluate existing equipment for launch and New Product Introduction
- Evaluate compliance of equipment with data integrity standards
- GMP Documentation authoring, review, and approval
- Continuous improvement of business and manufacturing processes
Hands on experience with equipment operation and experience with equipment commissioning, qualification, and validation is preferred. Knowledge of single-use equipment used in biopharmaceutical GMP production preferred. Experience working with computerized systems qualification and validation a plus. Good written and oral communication skills. Ability to work in a cross-functional team environment.
Bachelor’s degree in an engineering or biological-related science.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.
Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.