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 at client. The 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
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 send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.