MES Validation Engineer

Remote • Posted 1 day ago • Updated 14 hours ago
Contract W2
6 Months
Remote
Depends on Experience
Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

  • Computerized System Validation
  • CSV
  • Rockwell FactoryTalk PharmaSuite
  • LIMS
  • SCADA
  • ValGenesis
  • CQE
  • CSVS
  • MES validation
  • Life Sciences

Summary

MES Validation Engineer

  • W2 Only role.
  • Candidates must be authorized to work in the United States.
  • Sponsorship is not available for this position.

We are seeking an experienced MES Validation Engineer to support the deployment and validation of Manufacturing Execution Systems (MES) within a GMP-regulated pharmaceutical environment. The ideal candidate will have strong experience in CSV, MES validation, PharmaSuite, and validation lifecycle activities.

Key Responsibilities

  • Develop, execute, and document validation protocols, test scripts, traceability matrices, and validation reports.
  • Support MES implementation and validation activities in compliance with FDA, EMA, GxP, and CSV requirements.
  • Collaborate with IT, Quality, System Owners, and Business teams to define validation and testing strategies.
  • Execute formal validation activities and ensure compliance of computerized systems in a GMP environment.
  • Support risk assessments, testing execution, defect management, and validation documentation.

Required Qualifications

  • 5+ years of Computerized System Validation (CSV) experience in the pharmaceutical or life sciences industry.
  • Hands-on experience with Rockwell FactoryTalk PharmaSuite (MES).
  • Experience writing, executing, and validating test scripts, protocols, and traceability matrices.
  • Strong knowledge of FDA, EMA, GxP, and CSV regulatory requirements.
  • Experience with ValGenesis and regulated systems such as MES, LIMS, SCADA, or ERP platforms.
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
  • Experience managing validation testing plans and execution.
  • Professional certifications such as CQE or CSVS.
  • Strong communication and cross-functional collaboration skills.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10439527
  • Position Id: 8995037
  • Posted 1 day ago
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