MES MBR Designer - Small Molecule (Werum PAS-X) at Infinity Quest

REMOTE MID

Posted 7 days ago

Company snapshot

Infinity Quest (IQ) is a premier technology consulting partner offering a wide range of services including data science, Microsoft-related services, professional services, SAP, Salesforce, and RPA. With over 15 years of experience, IQ specializes in pr...

E-commerce Human Resources Consulting & Professional Services Information Technology & Services

HQ: Shirley, West Midlands, United Kingdom
Team size: 251-1K
Founded: 2006

Quick Summary

Role Overview

This role involves designing and building Werum PAS-X Master Batch Records for GMP small molecule and API manufacturing environments. The candidate will lead PAS-X migrations and version upgrades while ensuring compliance with regulated documentation standards.

Key Responsibilities

Design and build Werum PAS-X Master Batch Records.
Execute PAS-X migrations and major version upgrades from v2 to v3.4.
Configure MBR calculations, branching, and electronic signatures.
Manage material and equipment integration within the MES platform.
Perform testing and validation in a regulated GMP environment.
Handle change control and technical documentation processes.

Requirements Snapshot

Extensive hands-on experience with Werum PAS-X MBR design.
Proven track record with PAS-X migrations or version upgrades.
Expertise in GMP small molecule or API manufacturing processes.
Fluency in Italian and working proficiency in English.
Knowledge of testing and validation in regulated environments.

Expected Impact

The MBR Designer will ensure the successful transition and modernization of manufacturing execution systems through precise configuration and validation. This role directly supports operational efficiency and regulatory compliance within the production facility.

A DesignJobs.World summary of the employer's posting, written to highlight scope, requirements, and fit (AI-assisted, human-reviewed).
For full details, see the description below.

Job Description

Role PurposeOverall experience – Preference for experienced PAS-X MBR DesignersRelevant experience – Hands-on Werum PAS-X MBR design/build experience; experience with PAS-X migrations or major version upgrades, ideally PAS-X v2 to v3.4Mandatory skill required – Hands-on Werum PAS-X MBR design/build experience; experience with PAS-X migrations or major version upgrades (ideally v2 to v3.4); experience with GMP small molecule / solid dose or API manufacturing; MBR configuration including calculations, branching, e-signatures, exception handling and material/equipment integration; experience with testing, validation, change control and documentation in a regulated environmentGood to have skills – Global MES Template experienceRequired level of additional language – Italian (mandatory, fluent – project language); English (working proficiency)

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