Associate Engineer (JP4806)

Location: Thousand Oaks, CA
Date Posted: 10-02-2018
Job Title: Associate Engineer (JP4806)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration:36 months
3Key Consulting is looking for an Associate Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
Job Summary:
As a member of the process development team, this role will be focused on characterizing new fill finish technologies and advancing the state of the drug product manufacturing process at Amgen. The candidate will be primarily responsible for executing filler characterizations studies using complex fillers organizing data and analyzing results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. 
Engineer responsibilities include, but are not limited to, the following: 

• Independently design and execute experiments in order to characterize and enable implementation of new capabilities such as filling, lyophilization and analytical technologies 
• Serve as single point of contact and subject matter expert (SME) on complex capabilities. 
• Own business process and responsible for maintaining line time request forms and metrics 
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials 
• Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results 
• Troubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repair 
• Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures 
• Perform tasks related to safety and compliance initiatives in the lab. 
• Manage procurement and inventory levels of commonly used lab supplies and chemicals 
• Maintain SharePoints 

Top Must have Skill Sets:
1. Engineering, Chemistry or Pharmaceutical sciences, biotechnology degrees
2. Previous experience in protein/ biologics drug product/ drug substance manufacturing or process development labs
3. Ability to operate complex fillers, learn quickly and work independently.
Preferred Qualifications: 
• B.S. with 4‒6 years of industry experience, M.S. with 3‒4 years’ experience, with degree in Engineering 
• Previous experience in drug product/ drug substance manufacturing or process development labs 
• Knowledge of and hands-on experience with various drug product technologies, particularly filling technology 
• Displayed critical thinking, problem solving and independent research skills 
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies 
• Good computer and organizational skills with strong attention to detail 
Excellent communication (oral and written) 
• Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management 
• Self-motivation, adaptability and a positive attitude 
• Ability to work independently and as part of a team with internal and external partners.
Experience working in GMP environments or process development 
• Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses.

Day-To-Day Responsibilities:
1. Responsible for operating small scale to large scale fillers for executing process characterization studies. Transfer the process to clinical/ commercial site from a process development lab. Troubleshoot the filler to resolve any issue with support from other the system owner.
2. Independently design the study, execute, perform data analysis and reporting.
3. Drafting SOPs and maintaining trackers and involved in calculating line metrics.
4. Own the business process for requesting line time for a particular filler.
5. Work with other staff and provide support as needed to characterize other fill finish unit operations.
6. Maintain SharePoints and end of run forms.
Employee Value Proposition: The Building 6 pilot plant is one of the most advanced drug pilot plants. This job experience will help the person in process development and manufacturing allowing multiple options for growth.
 Red Flags: If the candidate is not truly interested in being on the floor and operating complex equipment (or) looking for a short term position, please don't put them in consideration. The training period for this position is 6-8 months. So in order to realize the value, the candidate should be willing to stay long term. Person should be able lift and move objects.
Interview Process: Would prefer both phone and in-person if he is a local candidate. For others, we can do phone/ skype with the hiring manager and the team.
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
3KC Talent Acquisition Team
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