Associate Engineer – Thermal Packaging Systems​/Cold Chain Logistics​/GMP Documentation & Pro

Job Title

Associate Engineer - Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support (JP15311)

Thousand Oaks, CA, 91320 (Hybrid)

Contract

Commercial Drug Product

6+ months (with likely extensions and/or conversion to permanent)

$28 - $34/hour W2

Only qualified candidates need apply. Hybrid Set Up - 2 days onsite per week.

Working Hours:

Standard 8AM - 5PM.

The Associate Engineer position is part of the Thermal Engineering Systems (TES) group at the client’s Thousand Oaks, CA facility. This role supports TES project management and documentation activities. Under the guidance of senior staff, the individual applies engineering principles and adheres to current SOPs to support the design, qualification, and implementation of thermal packaging systems. The role also assists with transportation laboratory testing, conducts experimental studies, and documents results in compliance with SOPs.

• Knowledge of GMP-Bio/Pharma background
• Project management and documentation
• Proven written and oral communication skills

• Track TES project progress and update project dashboard
• Author and revise controlled documents in the document management system
• Assist lab test execution and conduct characterization studies for TES projects
• Participate in shipping solution qualification projects
• Lead weekly team meetings to review project updates and facilitate team discussions
• Maintain and update the SharePoint project management dashboard to track progress
• Support shipping solution qualification projects and troubleshooting activities
• Assist with laboratory test execution, perform thermal experiments, analyze data, and generate reports
• Author and revise controlled documents (SOPs, PCS, RPTs, APPXs) within CDOCS and PLM systems
• Collaborate with cross-functional teams on protocol reviews, test preparation, change control processes, and deviation/CAPA management
• Utilize MS Office Suite (Excel, Word, Visio, PowerPoint, etc.) to develop documentation

• Bachelor degree OR Associate degree with 4 years of experience OR High school diploma / GED with 6 years of experience
• Bachelor’s degree in engineering or a related science field (biotechnology, chemical, or mechanical engineering preferred)
• Prior laboratory experience and knowledge of pharmaceutical GMP/GDP practices
• Experience with project management and GDocP (Good Documentation Practices) preferred
• Strong verbal and written communication skills
• Demonstrated ability to execute engineering tasks in accordance with SOPs and established procedures

• Candidates who lack relevant skills
• Candidates who do not meet the qualification requirements
• Candidates who were separated from previous employment due to unethical behaviors