Crystal Equation
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Engineer Senior
Top 3 Must Have Skill Sets:
Ideally looking for someone locally but open to someone who will relocate with the proper and strong sterlization experience
Summary:
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for our portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Responsibilities:
Basic Qualifications:
OR
OR
OR
OR
Preferred Qualifications:
Pay range is $38 - $43 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 Senior
360 Binney Street Cambridge, MA 02138 US
Posted: 02/18/2025
2025-02-18
2025-04-16
Job Number: 40257
Job Description
Engineer Senior
Top 3 Must Have Skill Sets:
- Sterilization experience
- Qualification/ quality experience
- Commercial process lifecycle management
Ideally looking for someone locally but open to someone who will relocate with the proper and strong sterlization experience
Summary:
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for our portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.
Responsibilities:
- support/ lead process development and commercialization of gas sterilization processes of combination products
- coordinate/ lead manufacturing site requirements to support sterilization requirements
- support the design control process and qualification of primary components
- support/ lead tech transfer projects for combination products
- support/ lead the development and operational improvements with key primary component suppliers
- support development of characterization methods for mechanical and physical properties of primary components
- support on-going deviation/ CAPA and change control
- support/ lead our supplier/ raw materials sterility assurance assessments
- collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
- drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences
Basic Qualifications:
- Doctorate degree
OR
- Master degree and 3 years of experience
OR
- Bachelor degree and 5 years of experience
OR
- Associate degree and 10 years of experience
OR
- High school diploma / GED and 12 years of experience
Preferred Qualifications:
- 3+ years in ethylene oxide or other gas sterilization processes
- 3+ years industry experience in sterility assurance of combination products
- 3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
- Strong problem-solving skills
- Capability to advance multiple projects in a fast paced environment
- Strong oral and written communication skills, decision making, presentation, and organization skills
Pay range is $38 - $43 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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