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Job Title: Engineer, Biopharma Process Development – Onsite/Hybrid (JP13727)
Location: Thousand Oaks, Ca.
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 12 months with possible extension of conversion to FTE
Posting Date: 02/20/2025
Rate: $36-41/Hr on W2 with benefits
Note: Must be local to Thousand Oaks. Staff should be a Flexible Commuter. - About 2-3 days per week onsite.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal Candidate:
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 over time.
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 various aseptic fill finish manufacturing plants and 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 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 communicate results to cross functional groups.
Qualifications
Supplement to the teams workload
Top Must-Have Skill Sets:
Day to Day Responsibilities:
Responsibilities include, but are not limited to, the following:
Red Flags:
Interview process:
1. 1:1 Interview With Hiring Manger
2. 1:1 Interview with Director Level
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 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.
Location: Thousand Oaks, Ca.
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 12 months with possible extension of conversion to FTE
Posting Date: 02/20/2025
Rate: $36-41/Hr on W2 with benefits
Note: Must be local to Thousand Oaks. Staff should be a Flexible Commuter. - About 2-3 days per week onsite.
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal Candidate:
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 over time.
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 various aseptic fill finish manufacturing plants and 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 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 communicate results to cross functional groups.
Qualifications
- Master’s degree OR Bachelor's Degree and 2 years of relevant experience
- Preferred Qualifications/Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
- Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
- Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
- Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
- Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
- Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
- Demonstrated ability to use interpersonal skills to build strong technical relationships.
- Self-motivation, adaptability, and a positive attitude.
Excellent communication skills, both oral and written.
Supplement to the teams workload
Top Must-Have Skill Sets:
- 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
Day to Day Responsibilities:
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
Red Flags:
- Not being team player
- Not have B.S. in Science/Engineering
- Fresh out of college.
Interview process:
1. 1:1 Interview With Hiring Manger
2. 1:1 Interview with Director Level
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 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.