Digital Engineer – POMS MES Remote W2 Hiring.

Posted 27 Days Ago
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Hiring Remotely in Chicago, IL, USA
In-Office or Remote
Expert/Leader
Software
The Role
Serve as a techno-functional POMS MES SME for pharmaceutical manufacturing. Configure, support, and implement MES solutions while bridging business, quality, validation, and IT teams. Ensure compliant electronic batch records, workflows, GMP/GxP operations, troubleshooting, documentation, and CSV validation. Support regulatory compliance with FDA 21 CFR Part 11 and GAMP 5. Experience with large-scale MES rollouts and ERP, LIMS, or SCADA integrations is advantageous.
Summary Generated by Built In
Job Description

Role: Digital Engineer – POMS MES Location: Remote | Start: Immediate | Interview: Phone/Skype

Summary: Seeking a POMS MES Techno‑Functional SME for pharma manufacturing (GxP). Role bridges business, quality, validation, and IT to configure, support, and implement MES solutions ensuring compliance and operational excellence.

Must‑Have Skills:

  • 8–12 yrs Pharma/Life Sciences exp, 5+ yrs POMS MES

  • Strong MES, EBR, workflows, GMP/GxP, CSV validation

  • Troubleshooting, documentation, compliance (FDA 21 CFR Part 11, GAMP 5)

Optional Skills:

  • Large‑scale MES rollout, ERP/LIMS/SCADA integration

  • ISA‑95, Agile/hybrid delivery, global manufacturing

 

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills Required

  • 8–12 years of pharmaceutical or life sciences experience
  • At least 5 years of POMS MES experience
  • Strong MES experience
  • Electronic batch record experience
  • Workflow configuration and implementation experience
  • GMP/GxP experience
  • Computerized System Validation experience
  • Troubleshooting and technical documentation experience
  • Knowledge of FDA 21 CFR Part 11
  • Knowledge of GAMP 5
  • Large-scale MES rollout experience
  • ERP, LIMS, or SCADA integration experience
  • ISA-95 knowledge
  • Agile or hybrid delivery experience
  • Global manufacturing experience
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The Company
HQ: Fremont, CA
35 Employees
Year Founded: 2004

What We Do

PDDN is a leading software engineering solution & Staffing solution provider focusing on enterprise wide solutions enabling its customers to realize best value on its investments. We have expertise in application development and professional staffing . We provide on-shore,off-shore and hybrid model for outsourcing. We also provide wide spectrum of IT services customized to client's needs. Please log on to our company website www.Pddninc.com

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