Engineer, Prefilled Syringe Design and Test; JP

Engineer, Prefilled Syringe Design and Test

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

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.

Top Must Have Skill Sets:

• Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
• GMP and GDP Technical Writing Skills
• CAD experience or knowledge (such as Solidworks)

Day to Day Responsibilities:

• 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.
• Author protocols, reports, and further technical documentation while adhering to GMP and GDP standards.
• Coordinate and execute 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.
• Maintain device and combination product design history files for assigned products.
• Provide 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.

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

Preferred Qualifications:

• Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Understanding of Mechanical Design Engineering Concepts
• Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
• Experience with design controls; including (but not limited to) design verification and transfer
• Understanding of risk assessments including hazard and probability analysis
• Experience with investigations and quality records
• Laboratory and electronic lab notebook experience
• Statistical Analysis software (Minitab or JMP)
• Experience with Instron force testers using Blue Hill Universal
• Test method development, GR&R, and text fixture design
• Ability to work independently and dynamically across functional teams
• Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
• Ability to support complex work streams under demanding timeline
• Understanding of the following standards and regulations:
  Quality System Regulation – 21
  
  CFR
  820;
  Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971; EU Medical Device Regulation – 2017/745

Red Flags:

• No GxP laboratory experience
• No GDP experience
• Only academic technical writing experience (non-industry setting)

Why is the Position Open? Backfill

Interview Process:

• Virtual 1 on 1 interview with hiring manager
• Virtual 1 on 1 interview with organization department manager
• Panel interview (2-3 colleagues)