POMS MES Engineer (4+ Yrs Exp., Contract, On-Site Role)

Job Title

POMS MES Engineer (4+ Years Hands‑On Experience)

Location

Worcester, Massachusetts

Contract placement with Top 10 global biopharma client

About Biostrategenix

Biostrategenix is a life sciences consulting and engineering firm focused on simplifying quality and manufacturing execution in highly regulated environments. We partner with pharmaceutical and biotech organizations to design and implement practical, compliant, and sustainable systems that support right‑first‑time manufacturing and faster batch release.

Our philosophy is grounded in clarity, lean principles, and data integrity. We design solutions that reduce complexity, eliminate waste, and align with global regulatory expectations—systems that work for manufacturing and quality teams, not against them. From MES and electronic batch records to quality system transformation, we help organizations move from reactive compliance to proactive operational excellence.

At Biostrategenix, engineers are expected to be hands‑on, technically deep, and accountable. We value people who understand how systems actually run in production and who want to build solutions that endure.

Position Summary

Biostrategenix is seeking a POMS MES Engineer with 4+ years of direct, hands‑on experience configuring and developing POMS or POMSnet Aquila solutions in GMP manufacturing environments.

This role is for an engineer who has written recipes, configured workflows, and built EBRs—not someone who has only used or administered POMS. You will support the full lifecycle of MES implementations, from requirements and design through testing, commissioning, and qualification, working closely with clients, quality teams, and cross‑functional stakeholders.

Key Responsibilities

POMS MES Configuration & Development

• Design, configure, and program POMS MES solutions, including:
  
• Master recipes, control recipes, and operations
  
• Electronic Batch Records (EBRs)
  
• Material, equipment, and process models
  
• Execution workflows and exception handling
  
• Apply S88 and S95 standards to recipe and system design.
  
• Configure POMS functionality to support GMP manufacturing processes, ensuring usability, traceability, and compliance.
  
• Participate in solution design discussions and contribute to system architecture decisions.
  

MES Project Execution

• Support MES projects across all lifecycle phases:
  
• Requirements gathering and functional specifications
  
• Configuration and build
  
• Unit testing, integration testing, and UAT
  
• Commissioning, qualification, and go‑live support
  
• Execute tasks independently while collaborating closely with senior engineers, project managers, and client teams.
  
• Troubleshoot system issues, perform root cause analysis, and implement sustainable fixes.
  

Systems Integration & Data Integrity

• Configure and support interfaces between POMS and external systems, including:
  
• ERP (e.g., SAP)
  
• DCS/SCADA (e.g., DeltaV)
  
• LIMS, QMS, CMMS
  
• Data historians (e.g., PI)
  
• Work with relational databases (SQL preferred) to support data validation, reporting, and troubleshooting.
  
• Ensure data integrity, audit readiness, and compliance across integrated systems.
  

Compliance & Documentation

• Ensure MES solutions meet cGMP, 21 CFR Part 11, and data integrity requirements.
  
• Author and support lifecycle documentation, including:
  
• Functional and configuration specifications
  
• Test scripts and test evidence
  
• Qualification deliverables (IQ/OQ/PQ support)
  
• Apply GAMP 5 principles throughout system design and implementation.
  

Requirements

Benefits