**Must be a U.S Citizen or Permanent Resident**

I have an exciting new opportunity with one of the industry's leading Biotech firms in Oxnard, CA - This position is Temp-Perm.

This position will lead a team to deliver custom and standard bioprocessing equipment solutions across the biotechnology product catalog. Through the analysis of the customer’s processes and user requirements, this position will lead a project team to assess and define engineered system solutions with the customer, provide quotes for the proposal including associated costing and execute the engineered solution based on defined contractual specifications.

This role is responsible for performing engineering activities to deliver custom and standard bioprocessing equipment solutions for the customer. This role works closely with project managers and senior engineers to ensure engineering solutions meet customer requirements, project schedule, and budget.

Provide technical support and design for Biopharma systems during project execution (PFAT, FAT, Installation, SAT, IV/OV). You will be hands-on with a wide variety of system testing including: bioreactors, columns, mixers, and other Products. You will have the chance to take ownership of all testing activities in accordance to project plan, closure of punch list items through collaboration with global team, and opportunity to interface with customers.

 

Essential Job Functions:


Communicates cross functionally effectively on financial status, progress monitoring, reporting, presentations and coordination of sub supplier activities (e.g. mechanical fabricators, electrical fabricators and software companies).
Participate in Continuous improvement processes and execute daily visual management.
Enter time into SAP and ensure updates are maintained.
Support testing activities both domestically and internationally for Biopharma systems in accordance to key-performance-indicators: according to specification, on time and within budget.
To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures.
Communicate effectively on technical / engineering issues internally as well as with the customer.
Troubleshooting of automated system components to identify root-cause of punchlist items identified during execution including mechanical, electrical, and automation issues.
Working in multidisciplinary team (manufacturing, quality, engineering, R&D, commercial, others) to investigate issues found, as well as optimize products to prevent re-occurrence in the future.
Provides conceptual and detailed designs using 3D CAD software (SolidWorks/Inventor). Uses tolerance analysis and stress calculations for design analysis.
Evaluates technical risks by leading DFMEA’s and ensuring accurate completion of required actions.
Helps develop project plans, stage gate deliverables, conducts design reviews, and anticipates project road blocks, delays and risks. Utilizes critical issue and communication techniques to problem solve.
Other duties as assigned.


Minimum Qualifications:


Bachelor’s degree in chemical/Mechanical/Biomedical Engineering or related field.
Understanding of Biotech Processes and Knowledge of the Biotech market is an asset;
Knowledge of GMP’s, GAMP, Validation, IQ/OQ Commissioning, SAT, FAT, SOP’s, OSHA.
Computer skills relating to general usage (Windows, Outlook, MS Office, etc.)
Excellent organization of time and ability to prioritize to meet tight deadlines.
Superior verbal and written communication skills, ability to deliver stellar reporting;
Strong team player with self-starting mentality;
Ability to develop relationships with customers;
Strive for continuous improvement;
Solution driven with strong problem solving and analytical skills;
Fluency in English. Knowledge of other languages is a plus.
Proficiency in 3D CAD modeling analyses, and simulations.
Experience working with external vendors (subcontractors) such as mechanical fabricators, material suppliers.
Skills in leadership, conflict resolution, and consensus building.


 


 

 

 
Why Kelly®?
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

About Kelly®

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.]]