Overview
Remote
Depends on Experience
Full Time
Skills
MES
EBR
MBR
Recipe
Pharma
Biotech
Life Sciences
ERP
SCADA
MES Platforms
Job Details
Location: Remote
Job Type: Full-Time / Contract
Industry: Life Sciences / Pharmaceuticals / Manufacturing
About the Role:
We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufacturing.
Key Responsibilities:
- Design, configure, and implement MES solutions with a focus on EBR/MBR development.
- Author and validate MES recipes based on manufacturing process requirements.
- Collaborate with cross-functional teams including process engineering, QA, validation, and IT to capture requirements and translate them into functional MES workflows.
- Conduct gap analyses and optimize existing MES configurations.
- Participate in system testing (IQ/OQ/PQ), validation documentation, and go-live support.
- Provide end-user training and technical support during deployment and post-implementation.
- Ensure MES solutions align with FDA regulations (21 CFR Part 11), GAMP 5, and other industry standards.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- 3+ years of experience with MES platforms (e.g., Werum PAS-X, Emerson Syncade, Siemens OpsCenter, Rockwell Pharma Suite, etc.).
- Proven expertise in EBR/MBR design and recipe authoring in MES systems.
- Strong knowledge of GMP compliance and validation practices.
- Excellent analytical, documentation, and communication skills.
- Ability to work independently in a fully remote environment.
Preferred Qualifications:
- Experience with pharmaceutical/biotech manufacturing processes.
- Familiarity with ISA-95/88 models and S88 batch control principles.
- Understanding of integration between MES and systems like ERP, LIMS, SCADA, or DCS.
- Certification in relevant MES platforms (if available).
What We Offer:
- Fully remote and flexible working environment.
- Competitive compensation.
- Opportunity to work on cutting-edge digital manufacturing initiatives.
- Supportive and collaborative team culture.
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