Apply to Drug Substance/Product Process Engineer, Tech Transfer - Biopharma (JP15405)

Job Title: Drug Substance/Product Process Engineer, Tech Transfer - Biopharma (JP15405)
Location: Thousand Oaks, CA (Hybrid)
Employment Type: Contract
Business Unit: Process Engineering
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $43 - $47/hour W2
Notes: Hybrid | 2 Days onsite , 3 days remote per week

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

Job Description:
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 internal manufacturing sites. The candidate will be 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 liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of company products. The candidate will assist in study design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups. The candidate will also be responsible for developing and maintaining trackers for project status and other key outputs for the team.

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 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 transfer documents, and change control assessments.
Support development of technology transfer tools (clinical and commercial) and automation of routine activities.
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
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, and AI

Preferred Qualifications:

B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug products / 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 elevate 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

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Strong cross functional team player with good communication skills (oral and written).
Good computer and organizational skills with strong attention to detail.
Strong technical/engineering background with critical thinking, problem solving and independent research skills. Team player and self starter.

Day to Day Responsibilities:

Author, review, and data verify documents related to drug product tech transfers
Collaborate with team members to develop and maintain trackers for key performance indicators
Participate in study design and execution of experiments

Red Flags:

High frequency of job changes
Overqualified for the role

Interview process:
Phone interviews. Available to start with interviews.

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.