Sr. PAS-X MES Engineer

Overview

Hybrid
$65 - $95
Contract - W2
Contract - 12 Month(s)

Skills

MES
SAP
GAMP
Documentation
Interfaces
MSI
Manufacturing Execution System
Data Integrity

Job Details

Job Title: Sr. PAS-X MES Engineer

Location: Remote for 6 months, then on-site at Springhouse, PA

Pay Rate: $65/hr-$95/hr (depending on experience)

Length of Assignment: 6-12 Months

Job Description:

Project Summary: Client is implementing a highly automated Manufacturing Execution System (MES) leveraging Krber PAS-X 3.4. This program will integrate MES with multiple external systems, including DeltaV, eLIMS, AVEVA PI, and SAP. The MES Engineer will play a critical role in configuring PAS-X, defining and testing workflows and interfaces, and supporting qualification/validation activities.

The MES Engineers will support:

  • PAS-X Configuration
  • Development and configuration of Master Batch Records (MBRs) using PAS-X 3.4.

Scope:

Approximately 3 gMBRs including the primary main CAR-T 7-day process

PVLs to support the gMBRs

Approximately 12 ESPs

Functional Specifications to describe gMBR functionality

Detail Design Specifications for gMBRs, PVLs and ESPs

Interface Definition & Testing

Define, configure, and test interfaces between PAS-X and connected systems (DeltaV, eLIMS, AVEVA PI, SAP, and other relevant systems) using PAS-X integration frameworks including the MSI Interface. Apply relevant protocols and standards such as OPC-UA, PI Asset Framework (AF), SOAP/RESTful APIs, and ISA-88/ISA-95 integration models.

Documentation

Deliver all work products in accordance with GAMP 5 documentation standards, ensuring alignment with 21 CFR Part 11 and data integrity principles.

The MES Engineer must demonstrate:

  • Familiarity with 21 CFR Part 11 requirements.
  • Strong understanding of data integrity principles (ALCOA+).
  • Experience applying GAMP 5 methodology for system lifecycle documentation.
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