3key Consulting, Inc.
Engineer, GMP Biotech Process Tech transfer (JP14599)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Overview
3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Details Job Title:
Engineer, GMP Biotech Process Tech transfer (JP14599)
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:
10/6/2025
Pay Rate:
$36 - $41/hour W2 with benefits
Basic Qualifications Master\'s Degree - 0 - 2 years industry experience
Bachelor\'s Degree - minimum of 2 years industry experience
Nice to have Tech transfer experience Preferably from BioPharma Industry
Job Description Ideal candidate: The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline with 1 – 3 years professional working experience. Candidates with recent Master degree are also suitable if they bring strong soft skills.
The candidate should possess solid working experience with standard software tools such as Microsoft Office. Experience with specialized software such as SAP or Smartsheet is desirable but can be learned on the job. Biologic drug product knowledge is favorable. The candidate must 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. Professional working experience outside of an academic setting is preferred.
Role Focus 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 Thousand Oaks, CA 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 supporting execution of characterization studies to generate technical data packages using complex technology, organization of data and analysis of results, and compiling information in concise summaries while under supervision of senior staff. The candidate will coordinate with drug product teams to facilitate technology transfer and complete technical documentation. The candidate will assist with experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups.
Preferred Qualifications
B.S. in scientific or engineering discipline with 1–3 years’ relevant professional experience or M.S. in scientific or engineering discipline with 0–2 years’ relevant professional experience
Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displays 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
Why is the Position Open? Supplement additional workload on team
Top Must Have Skills
Chemical Engineering, Biotechnology, and Pharmaceutical Science Industry related experience
Has been working on GMP environment
Preferably from BioPharma Industry
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 applicable software
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
Interview process Phone screening by hiring manager and panel interview. 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.
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Job Details Job Title:
Engineer, GMP Biotech Process Tech transfer (JP14599)
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:
10/6/2025
Pay Rate:
$36 - $41/hour W2 with benefits
Basic Qualifications Master\'s Degree - 0 - 2 years industry experience
Bachelor\'s Degree - minimum of 2 years industry experience
Nice to have Tech transfer experience Preferably from BioPharma Industry
Job Description Ideal candidate: The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline with 1 – 3 years professional working experience. Candidates with recent Master degree are also suitable if they bring strong soft skills.
The candidate should possess solid working experience with standard software tools such as Microsoft Office. Experience with specialized software such as SAP or Smartsheet is desirable but can be learned on the job. Biologic drug product knowledge is favorable. The candidate must 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. Professional working experience outside of an academic setting is preferred.
Role Focus 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 Thousand Oaks, CA 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 supporting execution of characterization studies to generate technical data packages using complex technology, organization of data and analysis of results, and compiling information in concise summaries while under supervision of senior staff. The candidate will coordinate with drug product teams to facilitate technology transfer and complete technical documentation. The candidate will assist with experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups.
Preferred Qualifications
B.S. in scientific or engineering discipline with 1–3 years’ relevant professional experience or M.S. in scientific or engineering discipline with 0–2 years’ relevant professional experience
Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displays 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
Why is the Position Open? Supplement additional workload on team
Top Must Have Skills
Chemical Engineering, Biotechnology, and Pharmaceutical Science Industry related experience
Has been working on GMP environment
Preferably from BioPharma Industry
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 applicable software
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
Interview process Phone screening by hiring manager and panel interview. 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.
#J-18808-Ljbffr