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Job Title: Engineer, Drug Product Fill/Finish Processing (JP13804)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 03/10/2025.
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
We are seeking a skilled Engineer who can work independently to support technical projects. The ideal candidate will have expertise in drug product fill/finish processing, holistic drug product process knowledge, technical transfer, drug product manufacturing, and regulatory filings. Excellent communication skills and proficiency in technical writing are essential for this role.
Our ideal candidate will have 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry. Open to previous job titles with more of a science background. (Ex: Scientist or Engineer previous titles). Key responsibilities include:
• Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
• Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
• Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
• Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
• Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
• Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.
Top Must Have Skill Sets:
• Drug product fill/finish
• Process development of drug product
• Technical writing
Day to Day Responsibilities:
• Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
• Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
• Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
• Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
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
Preferred Qualifications:
• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
• 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
• Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
• Experience with unit operations for parenteral manufacturing (e.g., filling, filtration, mixing), specifically lyophilization, is an advantage.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
• Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of drug product manufacturing.
• Demonstrated ability to work effectively in cross-functional teams to advance complex projects to completion.
Red Flags:
• Someone who has many jobs in the last year. Someone who is not local.
• Overqualified - 10+ years of experience
• Underqualified - Less than 3 years of experience with only a B.S
Why is the Position Open?
Supplement to the teams workload.
Interview Process:
• Phase 1, initial interview with hiring manager.
• Phase 2 interview with team and senior 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 (hybrid)
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 03/10/2025.
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
We are seeking a skilled Engineer who can work independently to support technical projects. The ideal candidate will have expertise in drug product fill/finish processing, holistic drug product process knowledge, technical transfer, drug product manufacturing, and regulatory filings. Excellent communication skills and proficiency in technical writing are essential for this role.
Our ideal candidate will have 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry. Open to previous job titles with more of a science background. (Ex: Scientist or Engineer previous titles). Key responsibilities include:
• Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
• Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
• Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
• Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
• Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
• Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.
Top Must Have Skill Sets:
• Drug product fill/finish
• Process development of drug product
• Technical writing
Day to Day Responsibilities:
• Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
• Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
• Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
• Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
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
Preferred Qualifications:
• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
• 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
• Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
• Experience with unit operations for parenteral manufacturing (e.g., filling, filtration, mixing), specifically lyophilization, is an advantage.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
• Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of drug product manufacturing.
• Demonstrated ability to work effectively in cross-functional teams to advance complex projects to completion.
Red Flags:
• Someone who has many jobs in the last year. Someone who is not local.
• Overqualified - 10+ years of experience
• Underqualified - Less than 3 years of experience with only a B.S
Why is the Position Open?
Supplement to the teams workload.
Interview Process:
• Phase 1, initial interview with hiring manager.
• Phase 2 interview with team and senior 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.