Associate Engineer - Biopharma GMP Background; JP

Position: Associate Engineer - Biopharma GMP Background (JP10606)
Job Title:Associate Engineer - Biopharma GMP Background (JP10606)
Location:Thousand Oaks, CA. (hybrid, remote and onsite)
Employment Type: Contract to Hire
Business Unit:U.S. FPT Process Engineering
Duration:18 months with likely extension or conversion to permanent
Posting Date:08/02/2022

3 Key Consulting is hiring an
Associate Engineer
for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This Associate Engineer position is in the Thermal Engineering Systems (TES) group  individual will lead TES project management and documentation. Under supervision by senior personnel, the individual will apply engineering principles and follow current SOPs to help execute the design, qualification, and implementation of thermal packaging systems. In addition, the individual will assist transportation lab test execution, conduct experimental studies, and document the results following SOPs.

Why is the Position Open?
Staff Augmentation

Top Must-Have Skill Sets:

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

Day to Day Responsibilities:

• Lead weekly team meetings to get project updates and discussion from TES team
• Update group dashboard and manage Smartsheet (Project Management) to track project updates
• Maintain TES SharePoint site and organize the group documents
• Participate in shipping qualification projects and trouble shootings
• Assist lab test execution and perform thermal experiments; conduct data analysis and generate report
• Author and revise controlled documents (SOPs, PCSs, TPC SOPs) in CDOCS and PLM system
• Collaborate with cross-functional teams (i.e. Research and Development, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory) on protocol review, testing preparation, change control process, and deviation & CAPA
• Excels in MS Office Suit (Excel, Word, Visio, PowerPoint, etc.)

Basic Qualifications:

• Engineering or Science degree, biotechnology, chemical or mechanical bachelors degree preferred. recent graduates welcome to apply
• Prior lab experience/knowledge on pharmaceutical GMP
• Prior project management & documentation experience
• Good oral/written communication skills

Employee Value Proposition:
The person in this position will work with a team to qualify shipping solutions for products to ensure they are maintained during transportation.

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 screening followed by in-person interview.

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role.
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