Lead I - Engineering Design

UST; Bengaluru; Remote; INR 1,200,000 - 1,800,000; Full time

Job summary

Thermo Fisher Scientific in India seeks a CSV Engineer to support the validation of PharmaSuite MES workflows for GMP production. You will own risk-based validation activities, write test scripts, and coordinate with US-based stakeholders to ensure compliant, validated electronic manufacturing records.

The role emphasizes eBR/eLogs validation, FDA 21 CFR Part 11 alignment, and cross-functional collaboration across Quality, IT, and MES teams. 3+ years of experience preferred.

Qualifications

• Hands-on CSV validation experience in pharmaceutical/biotech GMP manufacturing.
• Experience with validation deliverables, traceability, and release documentation.
• Knowledge of GAMP 5, data integrity (ALCOA+), and FDA 21 CFR Part 11.

Responsibilities

• Develop risk-based validation deliverables for Rockwell PharmaSuite MES workflows.
• Review requirements and MES workflows to reflect GMP and Greenville processes.
• Author and execute IQ/OQ/PQ or equivalent scripts for eBR/eLogs and MES.
• Coordinate remote validation with site SMEs, IT, and Quality; document evidence and results.
• Investigate validation test failures, deviations, and remediation activities.
• Maintain traceability, configuration/version control, and inspection readiness.

Skills

Attention to detail

Documentation

Issue investigation

Education

Bachelor’s degree in Engineering/CS/Life Sciences

Job description

Role Description

The CSV Engineer will support the implementation and validation of the Rockwell PharmaSuite Manufacturing Execution System (MES) at Thermo Fisher Scientific’s Greenville, North Carolina manufacturing site. Based in India, this role will work closely with Greenville Operations, Manufacturing Science and Technology (MSAT), Quality, IT, and MES delivery teams to ensure electronic manufacturing workflows are validated, fit for intended use, and ready for GMP production. Own and execute day-to-day CSV deliverables for configured PharmaSuite workflows, with particular emphasis on electronic batch records (eBR), electronic logbooks (eLogs), and associated manufacturing execution processes. Translate manufacturing requirements into risk-based validation evidence, manage test execution and deviations, and support an efficient transition from project implementation into a controlled, validated production state. What will you do?

• Develop and maintain risk‑based validation deliverables for Rockwell PharmaSuite MES workflows, including validation plans, requirements and specification traceability, risk assessments, test protocols, reports, and summary documentation.
• Review user requirements, process flows, and configured MES recipes/workflows to ensure testing reflects Greenville manufacturing processes and GMP requirements.
• Author, review, and execute IQ/OQ/PQ or equivalent lifecycle test scripts, with emphasis on functional and end‑to‑end testing of eBRs, eLogs, electronic signatures, audit trails, and exception handling.
• Coordinate remote validation execution with site subject‑matter experts, MES configuration teams, IT, and Quality; document objective evidence, defects, and test outcomes in approved systems.
• Investigate and resolve validation test failures, discrepancies, and deviations; support impact assessments, remediation, retesting, and closure in collaboration with the site.
• Maintain requirements‑to‑test traceability, configuration/version control evidence, and documentation supporting inspection readiness and release for GMP use.
• Assess system changes and workflow revisions for validation impact; support regression testing, change controls, and continued maintenance of the validated state.
• Participate in deployment readiness, user acceptance testing, go‑live support, and handover to site support teams; **escalate** risks to validation quality, schedule, or compliance promptly.
• Apply applicable site procedures and GxP expectations, including GAMP 5 principles, data integrity requirements, and FDA 21 CFR Part 11 as relevant to the implementation.
• Education Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field preferred; equivalent relevant validation experience will be considered. Required experience.
• Hands‑on computerized system validation experience in pharmaceutical or biotechnology GMP manufacturing, preferably 3+ years.
• Experience authoring and executing CSV protocols and managing validation deviations, traceability, and release documentation.
• Practical understanding of MES manufacturing workflows and the validation of configured applications, including recipe or workflow changes.
• Working knowledge of GAMP 5, data integrity (ALCOA+), electronic records/signatures, and applicable GMP regulatory expectations.
• Ability to work independently from India with US‑based stakeholders and to communicate clearly in written and spoken English.
• Preferred experience Direct experience validating Rockwell PharmaSuite MES including eBR and/or eLog workflows.
• Experience with electronic batch record execution, manufacturing exception handling, equipment/material workflows, and MES interfaces to enterprise or shop‑floor systems.
• Experience supporting US FDA‑regulated manufacturing facilities and geographically distributed deployment teams.
• Knowledge, skills, and abilities Strong attention to detail, structured documentation practices, and ability to investigate and close complex test issues.
• Ability to prioritize multiple deliverables, work across Operations, QA, IT, and technical teams, and meet project milestones.
• Willingness to maintain regular overlap with Greenville, North Carolina working hours and flex schedule for critical execution, testing, and go‑live activities.