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Sr Engineer - Manufacturing Execution System (MES)
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 08/22/2024
2024-08-22
2024-10-15
Job Number: 39598
Job Description
Sr Engineer - Manufacturing Execution System (MES)
Onsite or Remote
Top 3 Must Have Skill Sets:
In this vital role you will be a part of the Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics and for communication between the GMP operations teams and the process development scientific groups. This position will be focused Electronic Batch Records for Drug Substance manufacturing.
Responsibilities:
Onsite or Remote
Top 3 Must Have Skill Sets:
- MUST have strong PAS-X software experience for electronic batch records with detailed understanding of editing and validation
- Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
- Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
- No PAS-X experience
- Unable to speak to the experience listed on their resume
In this vital role you will be a part of the Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics and for communication between the GMP operations teams and the process development scientific groups. This position will be focused Electronic Batch Records for Drug Substance manufacturing.
Responsibilities:
- Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
- Validation of new Electronic Batch Records (Application Lifecycle Management)
- Assisting in implementation of new MES functionality (Equipment Management (EQM), PCS MBR Elements)
- Develop standard work and business practices for new MES functionality
- Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
- Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
- Doctorate Degree
- Master Degree and 3 years of Engineering experience
- Bachelor Degree and 5 years of Engineering experience
- Associate degree and10 years of Engineering experience
- High school diploma/GED and 12 years of Engineering experience
- Skilled with PAS X (Korber) software for electronic batch records with detailed understanding of GMBR design
- Experience with validation of GMBRs in a GMP environment
- Knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
- Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
- Demonstrated ability to work in a team
- Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology
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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.