Process Engineer II / Sr. Process Engineer

Fremont, CA 94555

Posted: 05/09/2019 Employment Type: Contract Industry: Clinical & Scientific Job Number: 15651

Bayside Solutions is seeking a Process Engineer II / Sr. Process Engineer to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.

Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Process Engineer II / Sr. Process Engineer

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
  • Work for a company that is local to the bay area and recognized as a leader of innovation.  
  • Competitive compensation commensurate with experience.
  • This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.

Summary of Responsibilities:
  • The Process Engineer II / Sr. Process Engineer will evaluate, qualify, and implement upstream (cell culture) and downstream (purification) process equipment in the single-use multi-product GMP manufacturing facility (Flextrain). The position will evaluate existing equipment for launch and commercial supply readiness as well as evaluate compliance with data integrity standards. The position will also drive troubleshooting 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 the client and external projects from clients (Contract Manufacturing Business).
  • Responsibilities include but are not limited to:
    • Evaluate existing equipment for launch and commercial readiness
    • Evaluate compliance of equipment with data integrity standards
    • Plan process-transfer activities according to timeline and quality
    • Plan back-up strategy for process equipment
    • Perform technical assessments
    • Contribute to NPI and technical risk analysis
    • Be point of contact for overall equipment qualification planning and execution
    • Provide input on how to maintain and improve plant technology
    • Continuous improvement of business and manufacturing processes

Required Qualifications:
  • Bachelor’ s Degree in an engineering or biological-related science.
  • 3+ years’ experience with equipment commissioning, qualification, and validation. 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.

Elizabeth Isabel

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