Crystal Equation
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Engineer
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
The Engineer, in Final Product Technologies- Mechanical Engineering 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 components. 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 expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
Responsibilities:
Basic Qualifications:
OR
OR
OR
Preferred Qualifications:
Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 02/25/2025
2025-02-25
2025-04-16
Job Number: 40293
Job Description
Engineer
Top 3 Must Have Skill Sets:
- Solid works Experience
- Technical Writing Skills
- Statistics Experience
Red Flags:
- No Solid works Experience
- No Technical Writing Skills
- No Statistics Experience
- Large gaps in employment
- No validation or qualification experience, must be able to manage multiple projects, lacking communication skills, and must be willing to be on site in Thousand Oaks when needed.
Summary:
The Engineer, in Final Product Technologies- Mechanical Engineering 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 components. 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 expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
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.
- 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.
- 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.
- Comply with the requirements, responsibilities, and authority as required.
- Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
- 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.
- Drives the cross-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 utilized 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 escalate efficiently.
- Integrates partner/vendor timelines with our timelines as appropriate.
Basic Qualifications:
- Master's Degree
OR
- Bachelor's Degree and 2 years of engineering/scientific experience
OR
- Associate's degree and 6 years of engineering/scientific experience
OR
- High school diploma/GED and 8 years of engineering/scientific experience.
Preferred Qualifications:
- M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
- Excellent written and verbal communication skills
- 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
- Technical writing experience
- Experience with SolidWorks (or other 3D-CAD software)
- Experience with combination products and regulatory requirements
- Experience utilizing Minitab (or other statistical software packages)
Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.