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

Biostrategenix LLC; Worcester (MA); On-site; Full time

Benefits offered by this job

Collaborative culture

Opportunity for growth in MES expertise

Impactful life sciences projects

Job summary

A consulting firm in life sciences is seeking a POMS MES Engineer to design and develop MES solutions within GMP environments in Worcester, Massachusetts. Candidates should have over 4 years of hands-on experience with POMS configuration and must support MES projects from inception to implementation. The role emphasizes technical skill and independence in task execution within a collaborative culture, making it ideal for those ready to impact operational excellence.

Qualifications

• 4+ years of direct, hands-on POMS MES experience in pharmaceutical manufacturing.
• Experience writing and configuring POMS recipes and EBR.
• Strong understanding of cGMP and 21 CFR Part 11 regulations.

Responsibilities

• Design, configure, and program POMS MES solutions.
• Support MES projects across all lifecycle phases.
• Ensure MES solutions are compliant with regulations.

Skills

POMS MES configuration

GMP manufacturing knowledge

Data integrity

S88/S95 standards

Technical writing

SQL proficiency

Education

Bachelor of Science in Engineering or Computer Science

Tools

POMSnet Aquila

SQL

Microsoft Office

Job description

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

About Us

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 Description

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 andengineering firm focused on simplifying quality and manufacturing executionin highly regulated environments. We partner with pharmaceutical andbiotech organizations to design and implement practical, compliant, andsustainable 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 formanufacturing 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
  
• ElectronicBatch Records (EBRs)
  
• Material,equipment, and process models
  
• Executionworkflows and exception handling
  
• Apply S88and S95 standards to recipe and system design.
  
• ConfigurePOMS functionality to support GMP manufacturing processes, ensuringusability, traceability, and compliance.
  
• Participatein solution design discussions and contribute to system architecturedecisions.
  

MES Project Execution

• SupportMES projects across all lifecycle phases:
  
• Requirementsgathering and functional specifications
  
• Configurationand build
  
• Unittesting, integration testing, and UAT
  
• Commissioning,qualification, and go‑live support
  
• Executetasks 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

• Configureand 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.
  
• Ensuredata integrity, audit readiness, and compliance across integrated systems.
  

Compliance & Documentation

• EnsureMES solutions meet cGMP, 21 CFR Part 11, and data integrityrequirements.
  
• Authorand support lifecycle documentation, including:
  
• Functionaland configuration specifications
  
• Testscripts and test evidence
  
• Apply GAMP5 principles throughout system design and implementation.
  

Requirements

Required Qualifications

Education

• Bachelorof Science in Engineering, Computer Science, or a related technicaldiscipline.
  

Experience

• 4+years of direct, hands‑on POMS MES experience in pharmaceutical orbiotech manufacturing.
  
• Demonstratedexperience writing and configuring POMS recipes and EBR.
  
• Experiencesupporting MES projects through implementation, testing, andcommissioning.
  
• Strongworking knowledge of:
  
• S88/ S95
  
• GAMP5
  
• cGMPand 21 CFR Part 11
  
• Experienceintegrating MES with ERP, DCS/SCADA, LIMS, historians, or related systems.
  
• Familiaritywith warehouse and inventory management in a GMP environment.
  
• Experienceworking with relational databases (SQL).
  
• Strongtechnical writing and communication skills.
  
• Proficiencywith Microsoft Office tools.
  

Preferred Qualifications

• Experiencewith POMSnet Aquila (on‑premise or cloud deployments).
  
• Exposureto cloud or hybrid MES architectures.
  
• Experiencesupporting commercial manufacturing operations.
  
• Abilityto mentor junior engineers or act as a technical resource within a projectteam.
  

Work Environment & Physical Requirements

• Combinationof office and on‑site manufacturing environments.
  
• Frequentuse of computers and technical documentation tools.
  
• Abilityto work in industrial settings, including standing, walking, andnavigating production areas as required.
  

Why Biostrategenix

• Workon meaningful life sciences projects with real operational impact
  
• Strongemphasis on technical depth and hands‑on engineering
  
• Collaborative culture focused on clarity and execution
  
• Opportunityto grow as a trusted MES subject‑matter expert
  

Biostrategenix LLC is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.