Apply to Associate Engineer, Fill/Finish Drug Mfg. - (JP11239)

Job Title: Associate Engineer, Fill/Finish Drug Mfg. - (JP11239)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: DP Process and Equipment Capabilities
Duration: 2+ years (with likely extensions)
Posting Date: 01/18/2023
Notes: Only qualified candidates need apply.

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, this role will be focused on characterizing new fill finish technologies and advancing the state of the drug product manufacturing process at 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?
Planned Project.

Top Must-Have Skill Sets:

Prior drug product internship or previous drug product work experience
Experience in large molecule development
Lab or manufacturing experience

Day to Day Responsibilities:

Support filling operations with operations of manufacturing size fillers
Performing experiments and data analysis
Participate in team presentations

Preferred Qualifications:

B.S. with 2‒3 years of industry experience, M.S. with 1‒2 years of experience
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

Employee Value Proposition:
Career growth, opportunity.

Red Flags:

Multiple jobs in short time frame.
Released from previous EW position due to behavior.
Pursuing additional education within 1 year.
Candidate should be enthuastic / highly motivated and willing to learn - this is a very technical and challenging job but is also very awarding.

Interview process:

30 min video conf interview with hiring manager (1 staff).

1 hr video conf interview with entire team (8 staff).
Possible 1 hr In-person interview on site in ATO (8 staff).

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.