Job Title
POMS MES Engineer (4+ Years Hands‑On Experience)
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 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
Required Qualifications
Education
- Bachelor
of Science in Engineering, Computer Science, or a related technical
discipline.
Experience
- 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.
Preferred Qualifications
- 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.
Work Environment & Physical Requirements
- Combination
of office and on‑site manufacturing environments.
- Frequent
use of computers and technical documentation tools.
- Ability
to work in industrial settings, including standing, walking, and
navigating production areas as required.
Benefits
Why Biostrategenix
- 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