MES Validation Engineer

DAWAR CONSULTING INC

MES Validation Engineer supporting validation of Manufacturing Execution Systems for a life sciences leader. Developing and executing protocols compliant with industry standards.

Posted 6/11/2026contractRemote • Oregon • 🇺🇸 United StatesMid-LevelSenior💰 $75 - $84 per hourWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System Validation (CSV)validation protocolstest scriptsrisk assessmentstraceability matricestesting plansIQOQPQUAT

Soft Skills

strong verbal communicationstrong written communicationcross-functional teamwork

Tools & Technologies

Rockwell FactoryTalk PharmaSuiteMESLIMSSCADAERPelectronic records systems

Industry Keywords

GMPFDAEMAGxPGAMP 521 CFR Part 11Data Integritychange controldeviationsCAPA

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Develop, author, review, and execute validation protocols, test scripts, and validation reports for MES and computerized systems.
Support implementation and validation of Rockwell FactoryTalk PharmaSuite and related manufacturing systems.
Collaborate with IT/OT, Quality Assurance, Manufacturing, System Owners, and Business Process Owners to ensure validation activities align with GMP requirements.
Develop validation strategies, risk assessments, traceability matrices, and testing plans.
Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification.
Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity requirements.
Support change controls, deviations, CAPA investigations, and audit readiness activities.
Manage testing execution, defect tracking, and validation deliverables throughout the project lifecycle.
Work with regulated systems such as MES, LIMS, SCADA, ERP, and electronic records systems.
Provide technical guidance on validation best practices and system compliance.

Requirements

What you’ll need

Bachelor's degree in Biomedical Engineering, Computer Science, Biology, Biochemistry, Chemistry, Biotechnology, Regulatory Affairs, Information Technology, or related Life Sciences field.
Minimum 5 years of experience in Computer System Validation (CSV) or Validation Engineering within a GMP-regulated environment.
Experience with Rockwell FactoryTalk PharmaSuite.
Strong knowledge of FDA, EMA, GxP, GAMP 5, and 21 CFR Part 11 requirements.
Experience authoring and executing validation protocols and test scripts.
Experience with risk assessments, change control, deviations, and CAPA processes.
Strong verbal and written communication skills.
Ability to work effectively in cross-functional teams.

Benefits

Comp & perks

Medical
Dental
Vision
Paid Sick leave
401K