Job Title: Associate Engineer Drug Product Manufacturing (JP10723 Location: Thousand Oaks CA. 91320 Employment Type: Contract Business Unit: DP Process and Equipment Capabilities Duration: 3 years (with possibility of conversion to permanent) Posting Date: 08/24/22 Notes: Only qualified candidates need apply.
3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description: 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 our client. 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
Manage dynamic project schedules and timelines
Why is the Position Open Team need for increased workload
Top Must Have Skills:
Selfmotivated
Familiarity with large molecule processing operations / biotechnology production
Technically capable and willing to learn.
Familiarity with Teams/ Sharepoint administration is a big plus.
Day to Day Responsibilities:
Support operation of commercial grade fillers and equipment
Scheduling data analysis coordination of operating activities to enable development filling experiments.
Writing reviewing and developing procedures formal data summary reports and SOPs for routine operation.
Preferred Qualifications:
B.S. with 23 years of industry experience M.S. with 12 years experience with degree in Engineering
Previous experience in drug product/ drug substance manufacturing or process development labs
Knowledge of and handson 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 linemanagement
Selfmotivation 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 1544lbs reach above and below shoulder height. Need color perception/discrimination far vision correctable with eye glasses
Employee Value Proposition: Career growth opportunity.
Red Flags:
Excessive shortterm positions in multiple companies in a short time window
Candidate searching to apply for higher education in the next 12 years
Candidate should have consistent industry experience (preferred)
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