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Biostrategenix LLC logoBiostrategenix LLC

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

Worcester, Massachusetts, United States · On-site

Mid level

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 Bios…

Skills: POMS MES Configuration, Electronic Batch Records, S88 Standard, S95 Standard, GAMP 5

Biostrategenix LLC logo

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

Biostrategenix LLC

Worcester, Massachusetts, United States • On-site

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Mid level

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  • Contract
  • bachelor degree
  • Meaningful Life Sciences Projects, Technical Depth Focus, Collaborative Culture, Professional Growth Opportunities
  • Posted 94d ago
  • ~40 hrs/week

Responsibilities

Design, configure, and program POMS MES solutions including master recipes and electronic batch records in a GMP environment. Support the full project lifecycle from requirements gathering and functional specifications through to commissioning and qualification.

Requirements

Requires a Bachelor's degree in Engineering or Computer Science and 4+ years of hands-on experience with POMS MES in pharma or biotech. Must be proficient in S88/S95 standards, GAMP 5, and integrating MES with ERP or SCADA systems.

Full job description

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


Related keywords

POMSMESPOMSnet AquilaGMPElectronic Batch RecordsEBRS88S95GAMP 521 CFR Part 11SAPDeltaVLIMSQMSCMMSPI Historian

About Biostrategenix LLC

LinkedInVisit site

Strategic Clarity. Enduring Impact.

Industry
Business Consulting and Services
Company size
2-10 employees
Founded
2025

At Biostrategenix, we believe that simplicity is the key to quality compliance. Our philosophy is grounded in lean 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 your teams with tools and processes that work for them, not against them. In this way, the solutions we implement, endure the test of time. Why Biostrategenix At Biostrategenix, we don’t just improve and implement quality systems. We build cultures of quality. We help your organization move from reactive compliance to proactive excellence, ensuring that every process is purposeful, every document is meaningful, and every decision is data-driven. We partner with you to build quality systems that are not only compliant but also agile, efficient, and sustainable. Whether you are launching a new site, integrating global QMS platforms, or streamlining SOPs, we bring clarity and structure to every part of your business. End result is that we accelerate quality compliance so that you can maximize shareholder value. Industry/Areas of Practice - Biopharmaceuticals, pharmaceuticals, and food - Quality, Manufacturing and Supply Chain - API, DS, DP, Packaging, Fill & Finish, Lyophilization - Biosimilars, CDMO, Generic - Tablets, SOD, Sterile Injectables (vials/ampoules)

QualityComplianceSupply Chain TransformationManufacturing ExcellenceRoot Cause AnalysisLean Six Sigma TrainingQuality Investigation TrainingQuality Maturity AssessmentsQuality Management System DesignSOP Optimization
View all jobs at Biostrategenix LLC

About Biostrategenix LLC

LinkedInVisit site

Strategic Clarity. Enduring Impact.

Industry
Business Consulting and Services
Company size
2-10 employees
Founded
2025

At Biostrategenix, we believe that simplicity is the key to quality compliance. Our philosophy is grounded in lean 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 your teams with tools and processes that work for them, not against them. In this way, the solutions we implement, endure the test of time. Why Biostrategenix At Biostrategenix, we don’t just improve and implement quality systems. We build cultures of quality. We help your organization move from reactive compliance to proactive excellence, ensuring that every process is purposeful, every document is meaningful, and every decision is data-driven. We partner with you to build quality systems that are not only compliant but also agile, efficient, and sustainable. Whether you are launching a new site, integrating global QMS platforms, or streamlining SOPs, we bring clarity and structure to every part of your business. End result is that we accelerate quality compliance so that you can maximize shareholder value. Industry/Areas of Practice - Biopharmaceuticals, pharmaceuticals, and food - Quality, Manufacturing and Supply Chain - API, DS, DP, Packaging, Fill & Finish, Lyophilization - Biosimilars, CDMO, Generic - Tablets, SOD, Sterile Injectables (vials/ampoules)

QualityComplianceSupply Chain TransformationManufacturing ExcellenceRoot Cause AnalysisLean Six Sigma TrainingQuality Investigation TrainingQuality Maturity AssessmentsQuality Management System DesignSOP Optimization
View all jobs at Biostrategenix LLC

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