Aditi Consulting ยท 5 hours ago
Sr Engineer - Manufacturing Execution System (MES), PASS-X
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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.
Qualification
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Required
Doctorate Degree or Master Degree and 3 years of engineering experience or Bachelor Degree and 5 years of engineering experience or Associate degree and 10 years of engineering experience or high school diploma/GED and 12 years of engineering experience
Must be very experienced in PAS-X
Integration with external program is also a requirement
Preferred
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
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
H1B Sponsorship
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2023 (24)
2022 (22)
2021 (27)
2020 (27)
Funding
Current Stage
Late StageRecent News
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