Payrate: $ 65.00- $ 70.00/ hr.
Description: Hybrid - Thousand Oaks, CA - Approximately 1 day per week onsite.
Ideal Candidate: - 5-10 years of experience.
- Manufacturing Execution System (Kroeber Client X) designer / validation experience - Candidates should be SME's in this
- Experience with Enterprise Resource Planning (SAP) software
- Experience with biotech manufacturing (Drug Product process)
Day to Day Responsibilities: - Manufacturing Electronic Batch Record (EBR) generation using Client-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 contribute to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.
- Engage with the rest of the network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working.
Basic Qualifications: Master's degree and 4 years of MES experience Or
Bachelor's degree and 6 years of MES experience Or
Associate's degree and 10 years of MES experience Or
High school diploma / GED and 12 years of MES experience
Preferred Qualifications: - Skilled with Client X (Korber) software for electronic batch records with detailed understanding of GMBR design
- Experience with validation of GMBRs in a GMP environment
- Knowledge of Client-X integration with external programs (SAP, PI, DeltaV, Rockwell)
- Strong operations knowledge of drug product manufacturing and a broad understanding of related disciplinary areas in bioprocessing
- Demonstrated ability to work in a distributed team
- Demonstrated ability to manage project deliverables and proactively engage with project stakeholders
- Degree in Chemical Engineering, Bioengineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology
Top 3 Must Have Skill Sets: - Manufacturing Execution System (Kroeber Client X) designer / validation experience
- Experience with Enterprise Resource Planning (SAP) software
- Experience with biotech manufacturing (Drug Product process)
- Strong project management skills - This person needs to be comfortable coordinating projects.
Pay Transparency: The typical base pay for this role across the U.S. is: $ 67.00- $ 70.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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