Engineer – GMP Physical Test Method Development & Validation (Combination Products) - (JP16052)
About The Position
The Engineer in Physical Methods is responsible for engineering activities involving the development, qualification, validation, transfer, and lifecycle support of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. Projects may involve new products or changes to products, processes, tooling, and equipment intended to improve quality and reliability and reduce cost. The work includes supporting manufacturing, new product introduction, training, and production. The Engineer develops and transfers test methods and assembly requirements for products such as vials, prefilled syringes, and injection devices. The role works across functions and with contractors, manufacturing, quality, regulatory, and vendors to coordinate deliverables, manage timelines and risks, support decision-making and issue resolution, and help ensure projects meet schedule and budget expectations. This is a contract consulting engagement in Thousand Oaks, California, with a minimum of three onsite days per week. The engagement is expected to last one year or longer, with likely extensions and/or conversion to permanent employment.
Requirements
- A master's degree; or a bachelor's degree and 2 years of engineering or scientific experience; or an associate's degree and 6 years of engineering or scientific experience; or a high school diploma/GED and 8 years of engineering or scientific experience.
- Ability to manage multiple projects simultaneously.
- SolidWorks experience, or experience with other 3D-CAD software.
- Technical writing experience and strong written and verbal communication skills.
- Experience with statistics or statistical software.
Nice To Haves
- M.S. in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or Chemistry.
- Two years of experience in the biotechnology or pharmaceutical industry.
- Two years of experience in equipment, method, and mechanical design.
- Experience with combination products and regulatory requirements.
- Experience with Minitab or other statistical software packages.
- Ability to work in a highly matrixed team environment.
- Validation or qualification experience.
Responsibilities
- Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
- Work with teams to transfer new combination-product test methods and assembly requirements to manufacturing, including developing Six Sigma processes and compiling manufacturing assembly documentation.
- Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
- Implement projects according to Final Product Technologies and company procedures, completing them on schedule and within established budgets.
- Coordinate test-method development and delivery with selected contractors.
- Ensure qualification parameters are met for product assembly requirements.
- Support cost estimates for new processes, gauges, and equipment development used in capital request documentation.
- Generate procedures to support the department and new process equipment.
- Gather test-method requirements to ensure equipment operates safely and considers ergonomic factors in its design.
- Maintain integrated timelines that capture cross-functional details and deliverables aligned with functional and project goals.
- Network internally and with manufacturing, quality, regulatory organizations, and external partners to align stakeholders and support project execution.
- Drive cross-functional communication and information integration to support decision-making, issue resolution, and change management throughout the project lifecycle.
- Communicate project status and risks associated with integrated timelines to leadership.
- Collaborate with functional leaders to support project success, momentum, and commitment.
- Identify issues and risks proactively and develop mitigation options for resolution or escalation.
- Integrate partner and vendor timelines with company timelines as appropriate.
- Perform other duties as required by the Group Manager and comply with applicable requirements, responsibilities, and authority.
Benefits
- Benefits are mentioned for the W2 contract role; specific benefits are not listed.
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What This Job Offers
Career Level
Entry Level
