Associate Process Engineer, Biopharma; JP

Position: Associate Process Engineer, Biopharma (JP10344)
Job Title: Associate Process Engineer, Biopharma - (JP10344)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: DP Process and Equipment Capabilities
Duration: 3 years
Notes: Only qualified candidates, please.
Posting Date: 06/02/22

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  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

Preferred Qualifications:

• B.S. with 2 years of industry experience, M.S. with 1 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

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:

• Self-motivated
• 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
• Scheduling, data analysis, coordination of operating activities
• Writing, reviewing, and developing procedures and SOPs for routine operation

Employee Value Proposition:
Unique experience/ setting/ opportunity.

Red Flags:

• Excessive short-term positions in multiple companies in a short time window
• Candidate searching to apply for higher education in the next 1-2 years
• Candidate should have consistent industry experience (preferred)

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to sendyour resume  Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.

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