Engineer, Biopharma Process Development – Onsite​/Hybrid; JP

Position: Engineer, Biopharma Process Development – Onsite/Hybrid (JP10834)
Job Title:Engineer, Biopharma Process Development – Onsite/Hybrid (JP10834)
Location:Thousand Oaks, Ca.
Employment Type:Contract
Business Unit:Commercial DP - Process Engineering (Clinical)
Duration:12 months with possible extension of conversion to FTE
Posting Date:09/20 /2022

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to various aseptic fill finish manufacturing plants and production lines.

The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of company products.

The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Qualifications

• Master’s degree OR Bachelor's Degree and 2 years of relevant experience
• Preferred Qualifications/Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
• Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
• Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
• Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
• Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
• Demonstrated ability to use interpersonal skills to build strong technical relationships.
• Self-motivation, adaptability, and a positive attitude.
  Excellent communication skills, both oral and written.

Why is the Position Open?
Staff Augmentation.

Top Must-Have Skill Sets:

• Minimum of Masters Degree, BS with 2+ years in Pharma, Medical Field
• Experiments, ensure completion of tasks, independently complete experiments
• Writing skills - writing documents
• Drug product/scientific principles- freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.

Day to Day Responsibilities:
Responsibilities include, but are not limited to, the following:

• The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects.
• The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff.
• The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of company products.
• The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Red Flags:

• No pharma experience, cannot work in teams, limited hands on experience.
• No background in Drug product/scientific principles- freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• No experience in writing documents

Interview process:
Phone screening followed by video Webex call

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