Engineer, Biotech Equipment and Facilities; JP

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

Job Title:

Engineer, Biotech Equipment and Facilities (JP11899);

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: 10/18/23;
Notes:
Only qualified candidates need apply. Fully onsite.

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at client in Thousand Oaks. The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

The Engineer role will provide direct engineering technical support as follows:

• Model leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for the consistent equipment performance.
• Be accountable for assigned deliverables on key capital projects.
• Suggest design modifications to address risks and design in quality and safety.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering 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.

• 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 Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
• Provide ad hoc technical support and guidance for manufacturing and maintenance
• Provide coaching and guidance to project teams and engineers using risk-based approaches
• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
• Participate in internal audits and assess in conjunction with quality assurance
• Assist in developing and maintaining business metric performance

• Fundamental client Leadership and Values - preferable to see former client workers
• Good Communication / Safety / Quality Focused
• Fundamental Technical Knowledge

• Support Epogen Commercial manufacturing equipment
• Model leadership behaviors and positive values to create a positive working environment.
• Be individually accountable for the consistent equipment performance
• Be accountable for assigned deliverables on key capital projects
• Suggest design modifications to address risks and design in quality and safety.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Act as a liaison between Engineering 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

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

• Bachelor's degree in engineering or another science-related field
• 7+ years of relevant work experience with 5+ years experience in operations/manufacturing environment
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities,…