Engineer - Combination Device Design, Development & LCM; JP

Position: Engineer - Combination Device Design, Development & LCM (JP14435)
Location: Newbury Park

Job Title: Engineer - Combination Device Design, Development & LCM (JP14435)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: PFS And Lyo Kit Platforms
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/27/25
Pay Rate: $36 - $41/hour W2
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:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Why is the Position Open?
Conversion backfill.

Top Must Have

Skills:

• Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
• Good Communication and Technical Writing Skills
• Statistical Analysis

Day to Day Responsibilities:
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems.

The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.

Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

• Adheres to strict documentation practices in a GMP regulated environment
• Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
• Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Maintains device and combination product design history files for assigned products
• Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications

Preferred Qualifications:

• Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Understanding of Mechanical Design Engineering Concepts
• Experie…