Crystal Equation
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Engineer Senior
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
Responsibilities:
Preferred Qualifications:
Basic Qualifications:
OR
OR
OR
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
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 09/30/2024
2024-09-30
2024-11-15
Job Number: 39783
Job Description
Engineer Senior
Top 3 Must Have Skill Sets:
- technical transfer, drug product manufacturing, regulatory filings
Red Flags:
- no experience or short tenures with other jobs.
- No experience owning and taking on projects.
- Not able to come onsite 3 days onsite.
Summary:
Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
Responsibilities:
- Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
- Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
- Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
- Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
- Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
- Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
- Identifies and implements operational opportunities for current and new sterile operations.
Preferred Qualifications:
- Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
- 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
- Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
- Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilisation would be an advantage.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
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
- High school diploma / GED and 12 years of experience
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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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.