Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13348)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 11/5/2024.
Notes: Only qualified candidates need apply. Initial schedule M-F for the first month of training. Flexibility in schedule, role has potential to move to a Sun-Wed 4 day x 10 hour shift (estimate start time 8 am)


3 Key Consulting is hiring!  We are recruiting an Engineer, Upstream Drug Development Facilities & Engineering for a consulting engagement with our direct client, a leading global biotechnology company. 

Job Description:
Our Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like CIP, COP, Autoclaves, and Glass Washers. Has a strong foundation in engineering principles, excellent communicator.

Seeking an Engineer at our client’s main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will provide on-site engineering support for the B23 Drug Substance Plant.

Under general supervision, provides equipment ownership by being SME of equipment. This position is to be the engineer for cleaning systems, which includes CIP (Clean In Place), COP (Clean Out of Place), Autoclaves and Glass Washers. Main function is to ensure equipment is running safely and reliably for production. Applies basic engineering principles to troubleshoot, design and implement system modifications, perform function tests for small projects. Organizes, analyzes and presents interpretation of results for engineering projects and/or issues of minor to medium scope and complexity. Support senior engineers for the implementation of complex projects.

Top Must Have Skill Sets:
•    Experience with regulated environments with working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech equipment.
•    Direct experience with manufacturing process equipment including troubleshooting, reliability and performance improvements, and design optimization.
•    Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
•    Must be able to communicate clearly. Required to communicate out issues and updates to broader audience.

Day to Day Responsibilities:
Equipment troubleshooting, improvement and reliability projects, ensuring that equipment WOs are completed on time

•    Function as a technical expert to equipment or systems.
•    Perform the system owner role for assigned systems to ensure equipment safety, reliability and compliance.
•    Work with manufacturing, maintenance, instrumentation, quality in order to resolve issues.
•    Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
•    Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
•    Specifying and overseeing a properly executed preventive maintenance program.
•    Specifying proper spare parts for system.

Basic Qualifications:
M.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.

Red Flags:
No troubleshooting or equipment ownership experience.

Why is the Position Open?
Supplement to the team’s workload.

Interview Process:
Interview with 3 engineers possibly in 1 to 2 interviews.
Can start interviewing ASAP.

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.