Digital Tulip MES Engineer 100 Remote
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Posted on:
2 hours ago
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Job Summary
Digital Tulip MES Engineer - 100% Remote
Location: 100% Remote
Job Type: Contract
Budget: 1.1 LPM
Experience: 2 - 5 Years
Key Responsibilities
1. Tulip Application Development & Deployment
Build and deploy GMPcompliant Tulip apps for:
Electronic batch records (EBR) and batch execution steps
Inprocess quality checks and sampling workflows
Equipment setup cleaning and line clearance verification
Material dispensing weighing and traceability
Deviation capture CAPA workflows and audit trails
Configure connectors to integrate Tulip with UNS ERP LIMS historians SCADA/PLC systems and other validated platforms.
Develop dashboards to provide realtime visibility into batch progress quality metrics and equipment performance.
2. Compliance Validation & Documentation
Ensure all Tulip applications comply with GMP GAMP 5 21 CFR Part 11 Annex 11 and data integrity (ALCOA) principles.
Create and maintain validation documentation (URS FRS IQ/OQ/PQ risk assessments change controls).
Partner with QA and Validation teams to ensure audit readiness and proper lifecycle management of digital systems.
Maintain secure traceable and compliant electronic records and audit trails.
3. Support Sustainment & Continuous Improvement
Provide daytoday support for Tulip apps connectors and edge devices in a validated environment.
Troubleshoot issues related to data integrity device connectivity and workflow logic.
Monitor system performance user adoption and data quality; drive continuous improvement initiatives.
Maintain version control documentation and change management in alignment with GMP expectations.
4. Workforce Training & Change Management
Train operators supervisors QA personnel and engineers on new Tulip workflows.
Develop SOPs training materials and job aids that meet regulatory documentation standards.
Promote a culture of digital adoption rightfirsttime execution and datadriven decisionmaking.
5. CrossFunctional Collaboration
Partner with QA Validation and IT/OT to ensure secure compliant and reliable infrastructure for Tulip deployments.
Collaborate with process engineering and operations to embed Tulip into new equipment processes and capital projects.
Work with corporate digital teams to align with enterprise architecture cybersecurity and digital strategy.
Qualifications
Bachelors degree in Engineering Computer Science Life Sciences or related field.
2-5 years of experience in pharmaceutical manufacturing process engineering or digital systems.
Handson experience with Tulip or similar lowcode MES/digital work instruction platforms.
Understanding of GMP GAMP 5 21 CFR Part 11 Annex 11 and data integrity requirements.
Experience validating computerized systems in a regulated environment.
Knowledge of SQL APIs OPC UA or IoT integrations.
Experience with Lean Six Sigma or operational excellence methodologies.
Familiarity with pharma systems (ERP LIMS MES SCADA PLCs).
Strong analytical and problemsolving skills with the ability to translate GMP workflows into digital solutions
Location: 100% Remote
Job Type: Contract
Budget: 1.1 LPM
Experience: 2 - 5 Years
Key Responsibilities
1. Tulip Application Development & Deployment
Build and deploy GMPcompliant Tulip apps for:
Electronic batch records (EBR) and batch execution steps
Inprocess quality checks and sampling workflows
Equipment setup cleaning and line clearance verification
Material dispensing weighing and traceability
Deviation capture CAPA workflows and audit trails
Configure connectors to integrate Tulip with UNS ERP LIMS historians SCADA/PLC systems and other validated platforms.
Develop dashboards to provide realtime visibility into batch progress quality metrics and equipment performance.
2. Compliance Validation & Documentation
Ensure all Tulip applications comply with GMP GAMP 5 21 CFR Part 11 Annex 11 and data integrity (ALCOA) principles.
Create and maintain validation documentation (URS FRS IQ/OQ/PQ risk assessments change controls).
Partner with QA and Validation teams to ensure audit readiness and proper lifecycle management of digital systems.
Maintain secure traceable and compliant electronic records and audit trails.
3. Support Sustainment & Continuous Improvement
Provide daytoday support for Tulip apps connectors and edge devices in a validated environment.
Troubleshoot issues related to data integrity device connectivity and workflow logic.
Monitor system performance user adoption and data quality; drive continuous improvement initiatives.
Maintain version control documentation and change management in alignment with GMP expectations.
4. Workforce Training & Change Management
Train operators supervisors QA personnel and engineers on new Tulip workflows.
Develop SOPs training materials and job aids that meet regulatory documentation standards.
Promote a culture of digital adoption rightfirsttime execution and datadriven decisionmaking.
5. CrossFunctional Collaboration
Partner with QA Validation and IT/OT to ensure secure compliant and reliable infrastructure for Tulip deployments.
Collaborate with process engineering and operations to embed Tulip into new equipment processes and capital projects.
Work with corporate digital teams to align with enterprise architecture cybersecurity and digital strategy.
Qualifications
Bachelors degree in Engineering Computer Science Life Sciences or related field.
2-5 years of experience in pharmaceutical manufacturing process engineering or digital systems.
Handson experience with Tulip or similar lowcode MES/digital work instruction platforms.
Understanding of GMP GAMP 5 21 CFR Part 11 Annex 11 and data integrity requirements.
Experience validating computerized systems in a regulated environment.
Knowledge of SQL APIs OPC UA or IoT integrations.
Experience with Lean Six Sigma or operational excellence methodologies.
Familiarity with pharma systems (ERP LIMS MES SCADA PLCs).
Strong analytical and problemsolving skills with the ability to translate GMP workflows into digital solutions
Required Skills:
DOCUMENTATIONAPISDIGITAL STRATEGYSQLMESCHANGE MANAGEMENTQUALITY METRICSQASCADAGMP
