Digital Tulip MES Engineer

shift - 1pm - 10pm

Duration - 6+ months

Remote

The Digital Tulip MES Engineer is a COE technical lead responsible for designing, deploying, and sustaining Tulip applications within a GMP regulated pharmaceutical manufacturing environment. This role blends process engineering, low code development, and compliance focused digital transformation to improve batch execution, documentation accuracy, deviation reduction, and overall plant performance. The engineer partners with QA, Operations, IT/OT, Validation, and corporate digital teams to ensure Tulip solutions meet regulatory requirements while driving operational excellence.

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Key Responsibilities

1. Tulip Application Development & Deployment

• Build and deploy GMP compliant Tulip apps for:

o Electronic batch records (EBR) and batch execution steps

o In process quality checks and sampling workflows

o Equipment setup, cleaning, and line clearance verification

o Material dispensing, weighing, and traceability

o 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 real time 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 day to day 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, right first time execution, and data driven decision making.

5. Cross Functional 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

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.

• 3–5 years of experience in pharmaceutical manufacturing, process engineering, or digital systems.

• Hands on experience with Tulip or similar low code 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 problem solving skills with the ability to translate GMP workflows into digital solutions

Digital Tulip MES Engineer

shift - 1pm - 10pm

Duration - 6+ months

Remote

The Digital Tulip MES Engineer is a COE technical lead responsible for designing, deploying, and sustaining Tulip applications within a GMP regulated pharmaceutical manufacturing environment. This role blends process engineering, low code development, and compliance focused digital transformation to improve batch execution, documentation accuracy, deviation reduction, and overall plant performance. The engineer partners with QA, Operations, IT/OT, Validation, and corporate digital teams to ensure Tulip solutions meet regulatory requirements while driving operational excellence.

________________________________________

Key Responsibilities

1. Tulip Application Development & Deployment

• Build and deploy GMP compliant Tulip apps for:

o Electronic batch records (EBR) and batch execution steps

o In process quality checks and sampling workflows

o Equipment setup, cleaning, and line clearance verification

o Material dispensing, weighing, and traceability

o 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 real time 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 day to day 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, right first time execution, and data driven decision making.

5. Cross Functional 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

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.

• 3–5 years of experience in pharmaceutical manufacturing, process engineering, or digital systems.

• Hands on experience with Tulip or similar low code 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 problem solving skills with the ability to translate GMP workflows into digital solutions