Associate Engineer (JP5050)

Location: Thousand Oaks, CA
Date Posted: 11-28-2018
Job Title:  Associate Engineer (JP5050)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  DSC Facilities and Engineering
Duration: 1+ years (likely extensions)
 
3Key Consulting Inc. is recruiting for an Associate Engineer with 1 - 3 years’ experience in the use and maintenance of bench-top analytical equipment, GMP documentation and equipment validation and ownership for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
The Associate Engineer will be responsible for the maintenance, ownership, and validation of the benchtop analytical systems in the company’s GMP Clinical and Commercial Manufacturing Facility. These off-the-shelf analytical instruments include TOC, cell counter, gas, particle counter, and metabolite analyzers.
  • The maintenance responsibilities include performing hands-on preventive maintenance, trouble shooting, and corrective maintenance on the floor in the plant. This will also include managing the vendors of the instruments and bringing them in-house to perform more extensive maintenance activities.
  • The ownership responsibilities include reviewing and improving both procedures and maintenance job plans, supporting investigations, using Maximo, and improving the overall reliability of the instruments.
  • The validation responsibilities include performing hands-on commissioning and qualification testing, reviewing testing protocols, and reviewing and approving reports generated by our validation partners.
 
In summary, the system owner is accountable for ensuring these instruments are operational, compliant, and reliable.
 
*** The ideal candidate will have experience with Use and Maintenance of Bench Top Analytical Equipment, GMP Documentation and Equipment Validation, Equipment Ownership.
 
Top Must-Have Skill Sets:
  • Use and Maintenance of Bench Top Analytical Equipment
  • GMP Documentation and Equipment Validation, Equipment Ownership
 
Day to Day Responsibilities
Learn how to operate and investigate issues on 2-3 of our benchtop analytical systems in B23
 Learn basic maintenance tasks and document completion of work orders
 Complete training and gain access to systems
 
Basic Qualifications:
  • The candidate must have an extensive experience using bench top analytical instruments, developing methods, and solving issues using science-based approaches.
  • In addition, the candidate must have a proven history of working in a GMP environment complying with Good Documentation Practices and partnering with Quality Assurance.
  • This individual must be able to work independently, prioritize tasks, and communicate progress and issues regularly and efficiently.
  • The candidate’s performance will be measured by their ability to work independently, comply with procedural requirements, and improve the reliability of these systems.
 
Preferred Qualifications:
  • The preferred candidate will have experience with these instruments commonly used in cell culture manufacturing facilities and a history of working in a plant environment on the floor.
 
Why This Position Is Open:
Increase production demand has increased our equipment support requirements
 
Employee Value Proposition:
Department is in the middle of tremendous growth and has a need for capable problem solvers. Our demand for talent is forecasted to last for years and there will be many opportunities to grow the role and pay accordingly.
 
Red Flags:
Lack of experience with complex, bench top analytical systems.
 
Interview process:
Phone followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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