Job Title:  Engineer, Drug Product Manufacturing / Processing - Hybrid (JP13084)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Commercial Drug Product Processing Group
Employment Type:  Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 8/14/2024.
Notes: Only qualified candidates need apply. MUST BE LOCAL to Thousand Oaks, CA. Consultant should be a Flexible Commuter. Consultant may be required to be onsite as needed based on business needs and can expect to be onsite on a weekly basis.


3 Key Consulting is hiring!  We are recruiting an Engineer, Drug Product Manufacturing / Processing for a consulting engagement with our direct client, a leading global biotechnology 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 the aseptic fill finish manufacturing plants at our client in Thousand Oaks, CA. 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 liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of 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 communicate results to cross functional groups.

Top Must Have Skill Sets:

• 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
• Strong cross functional team player with good communication skills (oral and written)

Day to Day 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 skills
• Support at scale characterization and/or process validation runs as person in plant

Basic Qualifications:

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
• This is a drug product processing group any familiarity with this (unit operations in scope of drug product would be very helpful!)
• Strong interpersonal skills, must be motivated to learn, willing and comfortable with asking questions when they don't understand something and taking direction (rather than tasking based on assumption)
• Strong ability to think critically build relationships
• Able to work in a fast paced nuanced environment
• Taking initiative

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

Red Flags:

• Experience on resume not reflective of actual work experience
• Not being able to take direct feedback and apply to task assigned
• Not having open communication and asking questions when there isn’t an understanding of process or task

Why is the Position Open?
Supplement additional workload on team

Interview Process: Phone first then virtual interview to follow.

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.