POMS MES Engineer (4+ Yrs Exp., Contract, On-Site Role)
Biostrategenix LLC•Worcester, MA
•Onsite
About The Position
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.
Requirements
- Bachelor of Science in Engineering, Computer Science, or a related technical discipline.
- 4+ years of direct, hands‑on POMS MES experience in pharmaceutical or biotech manufacturing.
- Demonstrated experience writing and configuring POMS recipes and EBR.
- Experience supporting MES projects through implementation, testing, and commissioning.
- Strong working knowledge of:
- S88 / S95
- GAMP 5
- cGMP and 21 CFR Part 11
- Experience integrating MES with ERP, DCS/SCADA, LIMS, historians, or related systems.
- Familiarity with warehouse and inventory management in a GMP environment.
- Experience working with relational databases (SQL).
- Strong technical writing and communication skills.
- Proficiency with Microsoft Office tools.
Nice To Haves
- Experience with POMSnet Aquila (on‑premise or cloud deployments).
- Exposure to cloud or hybrid MES architectures.
- Experience supporting commercial manufacturing operations.
- Ability to mentor junior engineers or act as a technical resource within a project team.
Responsibilities
- 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.
- 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.
- 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.
- 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.
Benefits
- Work on meaningful life sciences projects with real operational impact
- Strong emphasis on technical depth and hands‑on engineering
- Collaborative culture focused on clarity and execution
- Opportunity to grow as a trusted MES subject‑matter expert
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What This Job Offers
Career Level
Mid Level
