Recipe Author (Pharmaceutical MES) - Italian Speaker - Remote (Ascoli 2x times a month onsite)

Recipe Author (Pharmaceutical MES) - Italian Speaker - Remote (Ascoli 2x times a month onsite)

Job Title: Recipe Author (MES - Pharmaceutical Manufacturing)
Location: Remote - (Onsite 1x OR 2x a month in ASCOLI - Italy is mandatory)
Duration: 6-12 Months + Extension
Language Requirement: Fluent in Italian
Rate: €50 per hour, all inclusive

THIS PROJECT IS OUTSIDE IR35

Overview

We are currently seeking an experienced MES Recipe Author to join a pharmaceutical manufacturing team, supporting the digitization and optimization of batch record processes. The ideal candidate will bring deep domain knowledge of pharmaceutical production, particularly in solid oral dosage and packaging, and be proficient in building and validating Electronic Batch Records (EBRs) using MES platforms - preferably in the Pharma industry.

Key Responsibilities

• Collaborate with on-site Subject Matter Experts (SMEs) to translate paper-based batch records into MES-based EBRs
• Migrate Legacy EBRs from existing systems (eg, P2C2, PMX) into a new MES platform using existing functionalities
• Design modular, reusable building blocks for batch processes
• Create clear and compliant process maps using tools like Microsoft Visio
• Draft and maintain requirements, specification, and validation documentation in line with GMP and CSV standards
• Test and validate EBR functionality in a regulated pharmaceutical environment
• Ensure all documentation and practices align with Good Documentation Practices (GDP) and Good Testing Practices (GTP)
• Work within an Agile delivery environment, collaborating with a cross-functional team of developers, engineers, and QA professionals

Key Requirements

• Solid understanding of pharmaceutical manufacturing processes, especially solid oral dose and packaging
• Hands-on experience with MES platforms - strong preference for Pharma Domain
• Familiarity with Legacy MES systems (eg, P2C2, PMX)
• Proven experience authoring and testing Electronic Batch Records (EBRs)
• Strong grasp of Good Documentation Practices (GDP) and Good Testing Practices (GTP)
• Experience writing functional requirements, system specifications, and validation documents
• Proficient in Microsoft Visio (or similar process mapping tools)
• Ability to communicate effectively in Italian (written and spoken)
• Comfortable working in a fast-paced Agile team environment
• Onsite once or twice a month is mandatory in Ascoli in Italy