3 Key Consulting, Inc. · 5 months ago
Engineer, Biotech Tech transfer (JP14348)
Thousand Oaks, CA
Full-time
Onsite
Entry Level
$36/hr - $41/hr
1+ years exp3 Key Consulting, Inc. is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves supporting senior staff in the development and characterization of drug product technologies and manufacturing capabilities, while assisting in process validation and technology transfer projects.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc
Development of digital tools and models by leveraging data analytics and programming
Qualification
Required
Bachelor's degree in any engineering discipline
Solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's
Strong soft skills
Excel in group management
Deadline adherence
Meticulous documentation skills
Project development (PD) skills
Project management (PM) skills
Technical expertise expected to develop over time
Support senior staff to develop and characterize drug product technologies and manufacturing capabilities
Assist in the process validation and technology transfer of multiple products
Execute characterization studies and other experiments at the lab scale and production scale
Organize data and analyze results under supervision of senior staff
Interface with various drug product teams to ensure successful technology transfer
Establish the experimental design
Develop and execute protocols
Obtain reproducible and reliable results
Analyze and document experimental results
Communicate results to cross functional groups
Apply fundamental engineering and scientific principles to resolve issues
Assist in the design and execution of experiments
Support technology transfer leads during the transfer of drug products
Support development and maintenance of technology transfer tools
Effectively communicate results of characterization studies
Author/review/data verify technical documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc
Development of digital tools and models by leveraging data analytics and programming
Support at scale characterization and/or process validation runs as person in plant
Self-motivated
Willing to learn and explore
Self-sufficient
Preferred
B.S. in engineering discipline with 1‒3 years' experience or M.S. in engineering discipline with 0‒2 years' experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude
Benefits
With benefits
Company
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.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase