Engineer, Facilities, Equipment and Analytical support; JP

Position: Engineer, Facilities, Equipment and Analytical support (JP11900)
Job Title: Engineer, Facilities, Equipment and Analytical support (JP11900)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 1+ year(s) (with possible extensions)
Rate
: $38 - $42/hour W2
Posting Date: 10/18/2023
Notes: Only qualified candidates need apply. Fully onsite.

3 Key Consulting is recruiting an Engineer, Facilities, Equipment and Analytical Support for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at clients site in Thousand Oaks. The engineer will lead activities in alignment with clients’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment.

The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Top Must Have Skill Sets:

• Fundamental client Leadership and Values
  -preferable to see former client worker
• Good Communication / Safety / Quality Focused
• Fundamental Technical Knowledge.
• Person will be working in a manufacturing environment but in this posting, we are looking for an engineer with strong ANALYTICAL skills and background

Day to Day Responsibilities:
The engineer will lead activities in alignment with client’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps.

In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. The Engineer role will provide direct engineering technical support as follows:

• Be individually accountable for the verification deliverables on key capital projects.
• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
• Oversee development of validation protocols in line with CQP and cGMP standards.
• Lead, evaluate, and manage performance of contract resources.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.
• Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
• Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.
• Conduct and document periodic equipment validation reviews.
• Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)

• Related
  
  Activities:

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
• Support Lean Transformation and Excellence in…