Crystal Equation
http://cdn.haleymarketing.com/templates/61283/logos/crystalequation-socialmedia.png
https://www.crystalequation.com
https://www.crystalequation.com
true
Engineer
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
The 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:
Education:
OR
OR
OR
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.
Engineer
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 02/29/2024
2024-02-29
2024-05-22
Job Number: 38749
Job Description
Engineer
Top 3 Must Have Skill Sets:
- sterilization
- validation
- microbiology
Red Flags:
- Candidate must have gas sterilization background- radiation only is not sufficient
- Gas sterilization includes ethylene oxide (EO), steam, dry heat, vaporized hydrogen peroxide, nitrogen dioxide
Summary:
The 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 manufacturing site requirements to support sterilization requirements
- support the design control process and qualification of primary components
- support tech transfer projects for combination products
- develop specs of primary container closure systems for new and existing products
- support 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
Education:
- 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
Qualifications:
- 2+ years experience in gas sterilization process validation/ requalification's and sterility assurance microbiology
- strong technical writing skills***
- ISO 14937, ISO 11135
- 8+ years in ethylene oxide or other gas sterilization processes
- 2+ years industry experience in sterility assurance of combination products
- 5+ 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 $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.
Meet Your Recruiter
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Thousand Oaks, CA
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.