Job Description
Job Title
Tulip Application Engineer
Industry Domain
Pharmaceutical / Life Sciences (GxP-regulated Manufacturing)
Experience Required
5-10 years
Employment Type
Full-time
Location
Chennai/Coimbatore - Hybrid
Role Overview
We are seeking a Tulip Application Developer to design, build, validate, and maintain no-code/low-code manufacturing applications on the Tulip Interfaces platform within a GxP-regulated environment. This role bridges shop-floor digitization with strict quality, data integrity, and regulatory compliance requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). You will work cross-functionally with Manufacturing, Quality Assurance, Validation, and IT to deliver electronic batch records, digital work instructions, and real-time production monitoring solutions that meet cGMP standards
Key Responsibilities
- Design, develop, and deploy Tulip applications supporting GMP manufacturing operations, including electronic batch records (eBRs), digital work instructions, and in-process quality checks
- Ensure all Tulip apps are developed and maintained in accordance with 21 CFR Part 11, EU Annex 11, and Data Integrity (ALCOA+) principles
- Partner with Validation/CSV teams to author and execute User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ/PQ protocols, and traceability matrices for Tulip apps
- Build and maintain Tulip Tables, Triggers, and Connectors to integrate with LIMS, MES, ERP (SAP), and equipment/PLCs on the shop floor
- Implement audit trails, e-signatures, and role-based access controls within Tulip apps to satisfy Part 11 requirements
- Translate paper-based SOPs and batch records into validated, guided digital workflows
- Collaborate with QA on deviation/CAPA-related app changes and support change control processes for app modifications
- Support internal and external audits/inspections (FDA, EMA, notified bodies) by providing documentation and system walkthroughs for Tulip applications
- Develop dashboards for OEE, batch genealogy, deviation tracking, and quality metrics
- Maintain system lifecycle documentation (validation summary reports, periodic reviews, revalidation on updates)
- Train operators, supervisors, and QA staff on validated digital workflows
Required Technical Skillset
- 5+ years of experience with Tulip or similar no-code/MES platforms in a regulated manufacturing environment (pharma, biotech, medical device, or similar)
- Working knowledge of GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and computer system validation (CSV) practices
- Experience authoring or supporting validation documentation (URS, FS/DS, IQ/OQ/PQ, traceability matrices)
- Understanding of electronic batch records (eBR) and data integrity requirements (ALCOA/ALCOA+)
- Experience with Tulip Triggers, Tables, Connector Functions; basic JavaScript/REST API/JSON knowledge
- Experience integrating with LIMS, MES, SAP, or other quality/manufacturing systems
Familiarity with change control, deviation, and CAPA processes within a Quality Management System (QMS)
- Strong documentation practices suitable for audit readiness
- Excellent cross-functional communication with Quality, Validation, Manufacturing, and IT teams Pharmaceutical / Regulatory Domain Expertise (Preferred)
- Sound knowledge of GAMP 5 computerized system validation (CSV/CSA) lifecycle and documentation practices.
- Working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+) requirements.
Certifications (Preferred)
- Tulip Certified Basic/Advanced App Builder
- GAMP 5 / CSV training certification.
Soft Skills & Other Requirements
- Strong client-facing communication skills; ability to work directly with pharma quality, validation, and automation stakeholders.
- Ability to prepare and present technical estimations, proposals, and solution walkthroughs to client/hiring stakeholders.
- Strong documentation discipline suited to regulated/validated environments.
- Good analytical and troubleshooting skills for live plant support scenarios.