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Job Title: Engineer, Biotech Tech transfer (JP14348)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Process Engineering
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 07/31/25
Pay Rate: $36 - $41/hour W2 with benefits
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.
This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop overtime.
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at company site in Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of company products.
The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicating results to cross functional groups.
Responsibilities include, but are not limited to, the following:
Skills:
Scope includes a wide range of devices such as Cleaning Systems (Autoclave, Glassware Washers, Dryers, CIP/COP), Single Use Systems (TFF, VI/VF, Chrom). SS Systems (TFF, VI/VF, Chrom, Columns, Tanks, Pumps), and miscellaneous equipment. The qualified candidate will work with the manufacturing and engineering team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.
Why is the Position Open?
Supplement additional workload on team
Top Must Have Skills:
Red Flags:
Interview process:
1 Digital Panel (Hiring manager + team member)
for further progression, 1 Digital Discussion confirmation with Management
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Process Engineering
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 07/31/25
Pay Rate: $36 - $41/hour W2 with benefits
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.
This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop overtime.
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at company site in Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of company products.
The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicating results to cross functional groups.
Responsibilities include, but are not limited to, the following:
- 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
Skills:
- Support at scale characterization and/or process validation runs as person in plant
Preferred Qualifications: - 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
Scope includes a wide range of devices such as Cleaning Systems (Autoclave, Glassware Washers, Dryers, CIP/COP), Single Use Systems (TFF, VI/VF, Chrom). SS Systems (TFF, VI/VF, Chrom, Columns, Tanks, Pumps), and miscellaneous equipment. The qualified candidate will work with the manufacturing and engineering team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.
Why is the Position Open?
Supplement additional workload on team
Top Must Have Skills:
- Self-motivated
- Willing to learn and explore
- Self-sufficient
Red Flags:
- Limited prior working experience
- Frequent role changes in short timespans
- Unable to communicate working experience
- Over 6+ years of experience
Interview process:
1 Digital Panel (Hiring manager + team member)
for further progression, 1 Digital Discussion confirmation with Management
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.