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Sr Engineer - Manufacturing Execution System (MES)
Job Description
*Depending on experience
Sr Engineer - Manufacturing Execution System (MES)
Let’s do this. Let’s change the world. In this vital role you will be a part of the, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of New Product Introductions / Electronic Batch Record metrics and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on future-proofing and global transformation of Electronic Batch Records for Drug Product manufacturing.
Job scope and 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 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.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
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 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, 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
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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