Engineer, GMP Physical Test Methods - Hybrid (JP13129)

3 Key Consulting•Thousand Oaks, CA

13d•Hybrid

About The Position

The Engineer, in Physical Methods, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging parts. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Requirements

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
Technical writing experience
Strong communication skills
CAD experience (modeling, designing)
Experience managing their own workload independently

Nice To Haves

M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
Ability to work in a highly matrixed team environment
2 years of experience in the biotechnology/pharmaceutical industry
2 years of experience in equipment, method, and mechanical design
Experience with SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience applying Minitab (or other statistical software packages)

Responsibilities

Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new process equipment.
Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
Perform other duties as required by the Group Manager
Align with the requirements, responsibilities, and authority as required
Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work
Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
Networks with manufacturing, quality and regulatory organizations both internal and external to client
Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership
Collaborates with other functional leaders to ensure project success, momentum and commitment
Proactively identifies issues and/or risks and develops mitigation options to resolve or increase efficiently
Integrates partner/vendor timelines with client timelines as appropriate