Engineer Facilities & Manufacturing Operations; JP

Overview

Job Title: Engineer Facilities & Manufacturing Operations (JP11989)

Location: Thousand Oaks, CA. 91320

Business Unit: F&E Drug Substance Supply

Employment Type: Contract

Duration: 4+ months (with possible extensions)

Rate: $36 - $41/hour W2

Posting Date: 11/13/2023

Notes: Only qualified candidates need apply. Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.

3 Key Consulting is recruiting an Engineer Facilities & Manufacturing Operations for a consulting engagement with our direct client, a leading global biotechnology company.

This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.

• Engineering and technical background (process equipment, troubleshooting, data-driven tech skills)
• Teamwork experience
• Project improvement background

• Be individually accountable for the verification deliverables
• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
• Act as a liaison between Engineering and Manufacturing 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 verification exceptions have been adequately addressed
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• Related
  
  Activities:
• 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 on the CQP process and risk-based approaches to commissioning and verification
• Assist in developing and maintaining metrics
• Provide concise and clear documentation for actions taken on systems
• Oversee equipment vendors and contractors.

• Master’s degree OR
• Bachelor’s degree & 2 years of engineering and/or manufacturing experience OR
• Associate’s degree & 6 years of engineering and/or manufacturing experience OR
• High school diploma / GED & 8 years of engineering and/or manufacturing experience

• Bachelor's degree in engineering-related field
• 5+ years of relevant work experience with 3+ 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, facilities, instruments and equipment
• Experience implementing risk-based verification on major process equipment / automation projects, including validation protocol development and execution
• Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
• Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on…