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Job Description:
Role: Digital Engineer - POMS MES
Location: Remote
Duration: Long term
Job Description
Client is seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.
This role requires a combination of strong functional knowledge of pharmaceutical manufacturing processes, hands-on POMS MES expertise, and familiarity with CSV validation and regulatory compliance requirements.
Key Responsibilities:
MES Technical Responsibilities
Validation & Compliance Responsibilities
o User Requirements Specifications (URS)
o Functional Requirements Specifications (FRS)
o Design Specifications (DS)
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o Performance Qualification (PQ)
o Traceability Matrices
o Validation Summary Reports (VSR)
o FDA 21 CFR Part 11
o GAMP 5 Guidelines
o Good Manufacturing Practices (GMP)
o ALCOA+ and Data Integrity requirements
o Corporate Quality Management System procedures
What are the Mandatory skills and skill proficiencies required for this position?
What are the Optional skills and skill proficiencies for this position?
Fiekon is an innovative strategic IT services provider with a primary focus on workforce solutions.
Fiekon has evolved from the experience, exposure of many people, groups, organizations, industries, and subsidiaries nationally and internationally for a common purpose - global industries solutions focusing on the workforce solutions.
Fiekon works as an extension of our client talent acquisition teams and will be their brand ambassadors for them. At the same time, they are also key advocates of the candidates that Fiekon engages with and we provide them appropriate guidance and counselling in a timely manner. We work within a demanding environment which enables individuals to realize their full potential and where each individual's contributions are recognized and rewarded.
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