Job Title: Engineer, Drug Product – Prefilled Syringes (JP13400) 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/hour W2 with benefits Posting Date: 11/20/2024 Target Start Date: 01/06/2025 3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our client, a leading global biotechnology company. Ideal Candidate: has hands-on experience in engineering environments, especially with tools like Instron systems and optical measurement methods, proficiency in technical documentation, teamwork, and experience in regulated industries such as biopharma, biomedical, or medical devices. CAD/SolidWorks skills are a plus. Entry-level candidates with practical experience are preferred; overqualification is less desirable. Packaging engineering knowledge is a bonus but not mandatory. Job Description: The Device Engineer will participate in design, development, and lifecycle management activities for commercialized drug delivery devices, including mechanical delivery devices like prefilled syringes. Responsibilities include supporting combination product development from global launch to manufacturing, failure investigation, design change evaluation, testing, and continuous improvement. The engineer will maintain design history files, lead device design activities, and support product launches and inspections. Essential Skills and Responsibilities: Adheres to GMP documentation practices Competent in engineering principles, capable of independent judgment and problem-solving Authors and reviews technical documentation Analyzes data using statistical techniques Coordinates laboratory testing for characterization, verification, and design transfer Maintains design history files Develops characterization test methods Provides subject matter expertise in cross-functional activities Supports laboratory operations Works with scientists and engineers on specifications Represents device engineering within a large organization Familiar with standards like 21CFR820, ISO 14971, and EU Medical Device directives Preferred Qualifications: Bachelor’s or higher in Mechanical, Biomedical, or Bioengineering Minimum 2 years in a GMP environment Experience with statistical software (Minitab or JMP), CAD (SolidWorks), Instron testing Knowledge of design controls, risk assessments, manufacturing processes Strong communication and ability to work independently Top Must Have Skills: Technical documentation and testing coordination Independent judgment and problem-solving in engineering Day-to-Day Responsibilities: Support projects related to laboratory testing, lifecycle management, and product initiatives for prefilled syringes Author protocols and reports adhering to GMP standards Use Instron and vision systems for testing Lift up to 50 lbs as needed Support fill-finish processes (preferred but not mandatory) Basic Qualifications: Bachelor’s degree with 2 years’ experience, or equivalent Red Flags: Lack of practical engineering experience Poor communication skills Unwillingness to work on-site in ATO Weak technical writing No relevant industry experience Overqualified candidates (e.g., PhD with >3 years’ experience) Interview Process: Screening followed by team interviews. Qualified candidates should send their resume to recruiting@3keyconsulting.com . For other opportunities, visit our careers page . Feel free to share this opportunity with potential applicants. #J-18808-Ljbffr 3key Consulting, Inc.
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