MES Syncade Engineer – EBR & Recipe Authoring

AMTSOL : A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

MES Syncade Engineer – Recipe Authoring (EBR)
Location: Portsmouth, NH, USA

Role Summary

We are seeking an experienced MES Syncade Engineer to support GMP manufacturing sites across the USA East region. The role focuses on authoring, configuring, testing, and supporting Syncade MES recipes and Electronic Batch Records (EBR) to enable compliant, efficient, and right-first-time manufacturing execution.

Key Responsibilities

• Author, configure, and maintain Syncade MES recipes and EBRs

• Translate process descriptions and batch records into Syncade workflows

• Develop Master Recipes, Control Recipes, operations, phases, and material steps

• Configure equipment bindings, parameters, and operator prompts

• Support EBR execution, testing (UT, FAT, SAT, UAT), and go-live

• Support CSV activities (RA, IQ, OQ, PQ) in line with GAMP 5

• Ensure compliance with GMP, 21 CFR Part 11, and ALCOA+

• Support deviations, CAPA, and change control

• Collaborate with Process, Automation, QA, IT, and Operations teams

• Provide post–go-live manufacturing support and continuous improvement

Required Qualifications

• Bachelors degree in Engineering, Life Sciences, or equivalent experience

• 3+ years hands-on experience with MES Syncade, focused on recipe authoring / EBR

• Strong understanding of pharma / biotech manufacturing processes

• Experience in GMP-regulated environments

• Working knowledge of CSV and validation lifecycle