MES / PAS-X Engineer – Electronic Batch Records & Drug Product Manufacturing - (JP15933)

3 Key Consulting•Thousand Oaks, CA

6d•Onsite

About The Position

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.

Requirements

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
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
Experience learning new software / business processes
Experience in GMP environments and ability to follow an SOP / standard business process

Nice To Haves

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

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.
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