Job Description

An employer is seeking an 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.

* Support the End-to-End delivery of major Manufacturing application and platform development and support Services for our PAS-X MES system

* Identify optimization opportunities and execute to result in reduced Total cost of ownership while maintain established Service Levels. Establish standard processes.

* Lead extended, global, enterprise teams of internal and external professionals.

* Ensure execution excellence in the delivery of team and project objectives.

* Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.

* Assist in the delivery of application development and support services for Global and Regional and site-based MES systems, ensuring quality and timely delivery of services to consumers.

* Assist in support and delivery for existing manufacturing systems to ensure sites operate to business needs and issues are resolved as they arise.

* Provide innovative ways of problem solving and implementing system improvements.

* Act as subject matter expert on technical architectures and service platforms.

 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

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

o Security weaknesses in PAS-X.

o Experience with NTLM protocol

o 32 bit code vs 64bit code challenges

o Dependency on open source components BioPDF, PDF Writer.

o Known Java vulnerabilities.

o W32 TM protocol for NTP.

o ALM/TLM

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

o 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 - nextgen pasax exp

- Regulated industry experience

- Pharma experience

- CI/CD null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.