MES / PAS-X Engineer - Electronic Batch Records & Drug Product Manufacturing - (JP15933)
3key Consulting, Inc.
MES / PAS-X Engineer - Electronic Batch Records & Drug Product Manufacturing - (JP15933) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: Drug Product Supply Duration: 6+ months (with likely extensions and/or conversion to permanent) Posting Date: 10/2/26 Pay Rate: $62 - $67/hour W2 3 Key Consulting is hiring a MES / PAS-X Engineer - Electronic Batch Records & Drug Product Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Supporting a top-tier biotechnology company, this position functions within their Drug Product Supply organization at their Thousand Oaks, CA. location. 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 client network to assess EBR differences and identify path forward toward higher-effectiveness way-of-working. Why is the Position Open? Support additional workload Top Must Have Skills: MES PAS|X experience Attention to detail to turn process parameters / limitations to parameters in the electronic batch records Continuous Improvement mindset to help with on the floor troubleshooting and devise new, optimized solutions Day to Day Responsibilities: MES PVL/PMBR configuration for New Product Introductions Change Control impact assessments for New Product Introductions Minor GMBR design improvements On-call troubleshooting Operator training Basic Qualifications: Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of 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 Red Flags: Lack of experience learning new software / business processes Lack of experience in GMP environments and lack of ability to follow an SOP / standard business process Interview process: 30 min 1:1 with the hiring manager 45 min panel interview with the team (technical challenge) #J-18808-Ljbffr 3key Consulting, Inc.
$154.9k - $247.8k
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