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

Biostrategenix LLC

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. #J-18808-Ljbffr Biostrategenix LLC

Vacancy posted 2 days ago
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