3 Key Consulting, Inc.

Associate Engineer - Biopharma GMP Background (JP10606)

3 Key Consulting, Inc.  •  Thousand Oaks, CA (Hybrid)  •  17 days ago
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Job Description

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.



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
  • 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 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.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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