Physical Methods Engineer

2 weeks ago


Thousand Oaks, California, United States VetJobs Full time

Job Overview

ATTENTION VETERAN JOB SEEKERS - Our organization collaborates with partner companies to identify qualified candidates for their available positions. This opportunity is open to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you possess the necessary skills, educational background, and experience, we encourage you to proceed with the application process.

HOW WILL YOU INNOVATE?


You have dedicated yourself to your professional development and are now poised to advance your career.

How will you leverage your skills, experience, and enthusiasm to achieve your aspirations? At VetJobs, our collective mission—to support individuals—guides our every action.

This commitment is essential to our status as a leading organization, impacting countless lives. Join us in making a significant difference alongside other passionate professionals in this vital role.

Physical Methods Engineer

Your Responsibilities

Let’s embark on this journey together to make a positive impact.


The Physical Methods Engineer will oversee engineering tasks essential for the development, qualification, validation, and transfer of physical GMP testing methodologies for combination products, devices, primary containers, and secondary packaging components.

This role requires the ability to manage multiple projects simultaneously, which may involve modifications or the introduction of new products, processes, tools, or equipment aimed at enhancing quality and reliability while minimizing costs.


Project Phases Include:

Creating test methodologies for combination products, providing critical support for qualification, validation, transfer, and lifecycle management of methods for manufacturing, new product introduction, training, and production assistance.


Key Responsibilities
Develop, qualify, and validate GMP physical testing methodologies for vials, prefilled syringes, and injection devices.


Collaborate with teams to transition new combination product testing methodologies and assembly requirements to manufacturing by developing six sigma processes and compiling necessary documentation.

Develop, qualify, validate, and transfer new equipment, software, systems, and methodologies.


Execute projects in accordance with established procedures to ensure timely completion within budget constraints.

Provide expert support for investigations and new process development aimed at enhancing manufacturing operations.

Coordinate the development and delivery of testing methodologies with selected contractors.

Ensure compliance with qualification parameters for product assembly requirements.

Assist in developing cost estimates for new processes, gauges, and equipment needed for capital request documentation.

Create procedures to support departmental functions and new process equipment.

Deliver expert training to personnel on the operation and maintenance of processes, testing methodologies, and equipment introduced to Quality Control and/or the manufacturing department.

Engage in team functions as assigned (e.g., Product Improvement Teams).

Generate and maintain Test Method documentation.

Collect test method requirements to ensure equipment operates safely and ergonomically.

Perform additional duties as assigned by the Group Manager.

Align with the necessary requirements, responsibilities, and authority as needed.

Maintain integrated timelines by gathering relevant multi-functional details and aligning them with functional and project work.

Network internally to ensure alignment and commitment to project objectives and timelines, facilitating effective project execution.

Collaborate with manufacturing, quality, and regulatory organizations both internally and externally.

Drive multi-functional communication and information integration to optimize decision-making, issue resolution, and change management throughout the project lifecycle.

Utilize excellent verbal and written communication skills to convey project status and risks associated with integrated timelines to leadership.

Work collaboratively with other functional leaders to ensure project success and commitment.

Proactively identify issues and/or risks and develop mitigation strategies to enhance efficiency.

Integrate partner/vendor timelines with organizational timelines as appropriate.


This position may require occasional travel to assist development partners in implementing container closure integrity methodologies into their processes.


Qualifications

What we expect from you

We recognize that each individual brings unique contributions to our mission. The dynamic professional we seek will possess the following qualifications:

Basic Qualifications
Master's Degree OR

Bachelor's Degree with 2 years of engineering/scientific experience OR

Associate's degree with 6 years of engineering/scientific experience OR

High school diploma/GED with 8 years of engineering/scientific experience.

Preferred Qualifications
M.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or Chemistry

Exceptional written and verbal communication skills

Able to thrive in a highly matrixed team environment

2 years of experience in the biotechnology/pharmaceutical sector

2 years of experience in equipment, method, and mechanical design

Technical writing proficiency

Familiarity with SolidWorks (or other 3D-CAD software)

Experience with combination products and regulatory standards

Proficient in applying Minitab (or other statistical software packages)

What You Can Expect From Us


As we strive to develop solutions that benefit others, we also prioritize the professional and personal growth and well-being of our team members.

The anticipated annual salary range for this role is available upon request. Actual compensation will vary based on several factors, including relevant skills, experience, and qualifications.

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