Associate Engineer Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support

3Key Consulting is hiring an Associate Engineer Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

The Associate Engineer position is part of the Thermal Engineering Systems (TES) group at our client's Thousand Oaks, CA. facility. This role is responsible for supporting TES project management and documentation activities. Under the guidance of senior staff, the individual will apply engineering principles and adhere to current SOPs to support the design, qualification, and implementation of thermal packaging systems. In addition, the role includes assisting with transportation laboratory testing, conducting experimental studies, and documenting results in compliance with SOPs.

Top Must Have Skills:

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

Day to Day Responsibilities:

• Track TES project progress and update project dashboard
• Author and revise controlled documents in 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

Basic Qualifications:

• Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 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

Red Flags:

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

Interview process: Phone interview followed by in person interview onsite