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MES Consultant

Katalyst CRO

Role overview

Qualifications

  • Senior level GMP technical writing experience (must be a strong writer)
  • Experience revising controlled manufacturing documents and work instructions
  • Medical device manufacturing experience, ideally with knowledge of traceability requirements
  • Sufficient manufacturing or engineering knowledge to understand production processes

Responsibilities

  • Review and revise approximately 300 manufacturing work instructions and procedures to support both the existing paper process and the future Siemens Opcenter workflow
  • Preserve current paper based instructions in an appendix for use when MES is unavailable
  • Replace generic references with clear instructions for completing each step in Opcenter
  • Apply standardized language consistently across all documents

Key facts

Hard skills

Production Engineering Traceability

Other skills

  • Communication

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

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Job description

Important clarification:
This is not a traditional eQMS role. It is a manufacturing focused documentation project centered on production workflows and system inputs and outputs. The initial scope is limited to document updates, although one or both consultants may support additional projects depending on their experience and internal approval.
Job Description:
  • Our client is looking to add two contractors to update approximately 300 controlled manufacturing documents as the company transitions from paper based processes to Siemens Opcenter, its new Manufacturing Execution System. This is an urgent, multimillion dollar implementation with firm deadlines, and they would like the consultants to start as soon as possible.

Responsibilities:

  • Review and revise approximately 300 manufacturing work instructions and procedures to support both the existing paper process and the future Siemens Opcenter workflow.
  • Preserve current paper based instructions in an appendix for use when MES is unavailable.
  • Replace generic references with clear instructions for completing each step in Opcenter.
  • Apply standardized language consistently across all documents

Ideal background:

  • Senior level GMP technical writing experience (must be a strong writer).
  • Experience revising controlled manufacturing documents and work instructions.
  • Medical device manufacturing experience, ideally with knowledge of traceability requirements.
  • Sufficient manufacturing or engineering knowledge to understand production processes.
  • Familiarity with MES environments or electronic manufacturing workflows.
  • Ability to understand why information is being captured and translate technical requirements into clear instructions.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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