Process Engineer Senior Drug Product Tech Transfer JP13213
Process Engineer Senior Drug Product Tech Transfer JP13213
Posted on :
13-04-2025
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1 Vacancy
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Hourly Salary
$ 44 - 50
Vacancy
1 Vacancy
Posted on :
13-04-2025
Job Description
Job Title:Process Engineer Senior Drug Product Tech Transfer (JP13213
Location:Thousand Oaks CA. 91320 (Hybrid)
Business Unit:Commercial Drug Product
Employment Type: Contract
Duration:1 years with possible extension or conversion to FTE
Rate: $44 $50/Hours W2 with benefits
Posting Date:09/30/2024
Notes:On site minimum 3 days per week.
3 Key Consulting is hiring! We are recruiting a Senior Engineerfor a consulting engagement with our direct client a leading global biotechnology company.
Technical Skills: Drug product fill finish processing Holistic DP process knowledge.
Technical transfer drug product manufacturing regulatory filings.
Job Description:
Preferred Qualifications
Top Must Have Skill Sets:
Day to Day Responsibilities:
Create and update manufacturing process documents work with cross functional teams on product specific investigations complete laboratory investigations and perform routine testing monitor process data imitate and lead meetings related to product initiatives
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Why is the Position Open
Supplement additional workload on team.
Red Flags:
No experience or short tenures with other jobs.
No experience owning and taking on projects.
Not able to come onsite 3 days onsite.
Interview Process:
Phone/ Webex 23 rounds of interviews.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone 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 years with possible extension or conversion to FTE
Rate: $44 $50/Hours W2 with benefits
Posting Date:09/30/2024
Notes:On site minimum 3 days per week.
3 Key Consulting is hiring! We are recruiting a Senior Engineerfor a consulting engagement with our direct client a leading global biotechnology company.
Technical Skills: Drug product fill finish processing Holistic DP process knowledge.
Technical transfer drug product manufacturing regulatory filings.
Job Description:
- The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance while also leading the charge in innovative process improvement strategies.
- Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation filtration filling (vials/syringes/devices) and lyophilization of parenteral products.
- Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
- Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing Process Characterization Tech Transfer and Validation.
- Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Leads and participates in global crossfunctional teams working effectively in a highly matrixed team environment to influence and drive change efficiency and foster strong relationships.
- Troubleshoots issues with drug product processing technologies and equipment. Champions use of datadriven analyses and visualizations. Investigates to determine true root cause.
- Authors and reviews guideline documents technical protocols reports product impact assessments and regulatory submissions
- Identifies and implements operational opportunities for current and new sterile operations.
Preferred Qualifications
- Advanced degree in Chemical/Biomedical Engineering Pharmaceutical Sciences Chemistry/Biochemistry or Biotechnology or related field
- 10 years of drug product process development experience in the pharmaceuticals/biotechnology industry
- Knowledge of/handson experience with endtoend development for liquid and lyophilized drug products in various presentations
- Experience with unit operation for parenteral manufacturing (i.e. filling filtration mixing etc. specifically lyophilization would be an advantage.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freezethawing filtration mixing filling and/or lyophilisation 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 Quality systems Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to crossfunctional teams to advance complex projects to completion. Excellent communication skills are essential for this role as well as a demonstrated proficiency with the principles of Technical Writing.
Top Must Have Skill Sets:
- Specifically looking for downstream purification experience
- Strong communication must be comfortable speaking to a group of 20 manufacturing associates in presentation (data reviews/etc.
- GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)
Day to Day Responsibilities:
Create and update manufacturing process documents work with cross functional teams on product specific investigations complete laboratory investigations and perform routine testing monitor process data imitate and lead meetings related to product initiatives
Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Why is the Position Open
Supplement additional workload on team.
Red Flags:
No experience or short tenures with other jobs.
No experience owning and taking on projects.
Not able to come onsite 3 days onsite.
Interview Process:
Phone/ Webex 23 rounds of interviews.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
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