POMS MES Engineer On-Site
Listed on 2026-06-12
-
Manufacturing / Production
Systems Engineer
Worcester, United States | Posted on 03/26/2026
- Industry Pharma/Biotech/Clinical Research
- Work Experience 4-5 years
- City Worcester
- State/Province Massachusetts
- Country United States
AtBiostrategenix, we believe thatsimplicity is the key to quality compliance. Our philosophy is grounded inlean principles, where every process is designed to reduce complexity, eliminate waste and enhance value.
We approach quality with clarity and purpose by designing systems that are intuitive, scalable, and aligned with global regulatory expectations. Our goal is to empower our clients' teams with tools and processes that workforthem, not against them. In this way, the solutions we implement endure the test of time.
Job Title
Location
Worcester, Massachusetts
ON SITE – 5 days/week
Minimal Travel up to 10%
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 executionin highly regulated environments. We partner with pharmaceutical andbiotech organizations to design and implement practical, compliant, and sustainable systems that support right‑first‑time manufacturing and fasterbatch release.
Our philosophy is grounded in clarity, lean principles,and data integrity. We design solutions that reduce complexity, eliminatewaste, and align with global regulatory expectations—systems that work for manufacturing and quality teams, not against them. From MES and electronicbatch records to quality system transformation, we help organizations move fromreactive compliance to proactive operational excellence.
At Biostrategenix, engineers are expected to be hands‑on,technically deep, and accountable. We value people who understand howsystems 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 orPOMSnet 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 oradministered 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:
- Masterrecipes, control recipes, and operations
- Electronic Batch Records (EBRs)
- Material,equipment, and process models
- Executionworkflows and exception handling
- Apply S88and S95 standards to recipe and system design.
- Configure
POMS functionality to support GMP manufacturing processes, ensuringusability, 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
- Configurationand 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.
- Troubleshootsystem issues, perform root cause analysis, and implement sustainablefixes.
Systems Integration & Data Integrity
- Configure and support interfaces between POMS and external systems, including:
- ERP(e.g., SAP)
- LIMS,QMS, CMMS
- Workwith 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 integrityrequirements. - Authorand support lifecycle documentation, including:
- Functionaland configuration specifications
- Test scripts and test evidence
- Apply GAMP5 principles throughout system design and implementation.
Required Qualifications
Education
- Bachelor of Science in Engineering, Computer Science, or a related technical discipline.
Experience
- 4+years of direct, hands‑on POMS…
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