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Sr. PAS-X Engineer

2 months ago

Jersey City, United States Fusion Life Sciences Technologies LLC Full time

Must-haves

Strong MES PAS-X expertise - Extensive experience with Werum PAS-X MES, specifically version 3.1.8.

Security weaknesses in PAS-X.

Experience with NTLM protocol

32 bit code vs 64bit code challenges

Dependency on open source components BioPDF, PDF Writer.

Known Java vulnerabilities.

W32 TM protocol for NTP.

ALM/TLM

Experience with Oracle and/or Postgres SQL databases used with PAS-X.

Experience with data migration. Describe what approaches and tools they have used

PDA Integration experience (process Data Acquisition)

DeltaV system integration experience

Application Architect + deployment experience (system support/custom configuration/performance optimization)

Understanding system architecture from an MES perspective (not just working within MES and knowing how to use the controls but understanding how the system integrates, how controls were built, how to admin the system and troubleshoot in the event of an issue)

Understanding quality constraints and responses from an FDA perspective (how quality impacts and what documents need to be followed for a change Pas change of system update (what SDLC/manufacturing docs need to be updated)

Experience supporting Supply Chain/Manufacturing Systems

Plusses

nextgen pasax exp

Regulated industry experience

Pharma experience

CI/CD

Day-to-Day

An employer is seeking an Organization MES Engineer for a large pharmaceutical client. This individual will be Reporting to the lead engineer and will be mentored by this individual. They will be Responsible for maintaining p1 p2 tickets as they run through patches. They will also be managing communication with teams patching schedule and ensuring patching goes smoothly as well as supporting the PO in defining the strategy for the technical solutions (what opportunities are in the business where there are challenges in the system and how to make them better). They have 30 sites - 15-20 system configs between those sites and its an extremely complex environment.

Have you led teams that have led projects for MES deployments

Have you been a part of a team that has led MES deployments

Have you done product development/support type of work

Do you understand CI/CD pipelines? (understanding and executing)

The interview will be Scenario based + technical - In the event this happens what would you/How have you handled a similar situation like this

PDA Integration: In-depth knowledge and hands-on experience with Process Data Acquisition (PDA) integration within the PAS-X environment.

DeltaV System: Proficient in integrating and working with Emerson's DeltaV Distributed Control System (DCS) in conjunction with PAS-X MES.

Application Architecture: Strong understanding of PAS-X application architecture, including system design, configuration, and optimization for manufacturing operations.

Deployment Experience: Proven experience in deploying and upgrading PAS-X systems, ensuring minimal disruption and maximum efficiency.

System Support: Proven track-record of providing comprehensive support for PAS-X applications, including troubleshooting, issue resolution, and system maintenance.

Custom Configuration: Skilled in configuring and customizing PAS-X to meet specific manufacturing requirements, including the development of workflows, reports, and interfaces.

Validation Expertise: Experience in supporting validation activities, including IQ/OQ/PQ documentation and execution for PAS-X systems.

Integration Knowledge: Familiar with integration of PAS-X with other enterprise systems such as ERP, LIMS, and SCADA.

Performance Optimization: Ability to analyze system performance and implement optimizations to improve the efficiency and reliability of PAS-X.

User Training: Experience in developing and delivering training sessions for end-users on PAS-X functionalities and best practices.

Regulatory Compliance: Strong understanding of GMP, GAMP5, and other regulatory requirements related to PAS-X deployment and operation.

Project Management: Experience in managing or participating in PAS-X-related projects, from requirement gathering to post-deployment support.

Technical Documentation: Proficient in creating detailed technical documentation, including system designs, user manuals, and SOPs for PAS-X.

Cross-functional Collaboration: Ability to work effectively with cross-functional teams, including IT, quality, and manufacturing, to ensure successful PAS-X implementation and support.