Engineer, Drug Product – Prefilled Syringes; JP

Engineer, Drug Product – Prefilled Syringes

Engineer, Drug Product – Prefilled Syringes

Location:

Thousand Oaks, CA

Business Unit: PFS And Lyo Kit Platforms

Employment Type:

Contract

Duration: 12 months with likely extensions or conversion to perm

Rate: $36-41/hours W2 with benefits

Target

Start Date:

01/06/2025

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

Has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable. Proficiency in Microsoft Office is required, and CAD/Solid Works skills are a plus. Entry-level candidates with practical experience, such as internships, are preferred, while over qualification (e.g., PhD or advanced degrees with extensive experience) is less desirable.

Packaging engineering knowledge is a bonus but not mandatory.

The Device Engineer will participate in the design, development, and lifecycle management 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.

• Adheres to strict documentation practices in a GMP regulated environment
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintains combination product design history files for assigned products
• Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• 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
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
• At a minimum familiar with the following standards and regulations:
• Quality System Regulation – 21
  
  CFR
  820
• Risk Management – ISO 14971
• EU Medical Device requirements – Council Directive 93/42/EEC

• Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 2 year of scientific or engineering experience in a GMP regulated environment
• Statistical Analysis software (Minitab or JMP)
• Strong technical…