This role involves leading Pharma/Biotech MES implementations, designing EBRs, workflows, and recipes, and supporting testing, validation, and compliance activities.
Company Description
👋🏼We're Nagarro.
We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (17700+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We're looking for great new colleagues. That's where you come in!
Job DescriptionREQUIREMENTS
- 9+ years of experience in Pharma / Biotech MES implementations
- Hands-on experience with Siemens Opcenter and recipe authoring (mandatory)
- Experience in EBR design, MBR development, and S88 standards
- Strong knowledge of GxP, CSV, and 21 CFR Part 11
- Understanding of pharmaceutical manufacturing processes and biotechnology products
- Experience in validation activities (IQ, OQ, PQ, RTM), risk and gap analysis
- Exposure to MES integrations and solution architecture
- Strong communication, documentation, and stakeholder management skills
- Experience leading teams or complex projects is preferred
RESPONSIBILITIES
- Conduct discovery workshops, requirement gathering, and process analysis
- Design recipes, workflows, and Electronic Batch Records (EBR) aligned with MBR and S88
- Execute dry runs, testing, and validation before Go-Live
- Support MES implementation, integrations, and production issue resolution
- Prepare and manage validation plans and documentation
- Participate in audits, compliance activities, and cGMP requirements
- Support solution design, integrations, and system configurations
- Troubleshoot issues during testing, validation, and deployment
Bachelor’s or master’s degree in computer science, Information Technology, or a related field
Top Skills
21 Cfr Part 11
Csv
Ebr
Gxp
Mbr
S88
Siemens Opcenter
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