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Master’s in Pharma & Biotech Automation Engineering

Online master's programme of 1,900 hours in Pharma & Biotech automation engineering. 12 modules covering GMP, computerised system validation to GAMP 5, data integrity, bioprocess and batch automation, sterile manufacturing, PAT and serialisation, with an assigned technical tutor.

Duration1900 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
Enrol now View syllabus Ask an advisor

Master’s in Pharma & Biotech Automation Engineering — studying from India

India's automation and robotics market is growing with the expansion of manufacturing, automotive and electronics production. Industrial automation firms such as ABB, Siemens, Fanuc and Bosch operate in the country, alongside domestic integrators and start-ups in Bengaluru, Pune, Chennai and Hyderabad. Research institutions including the Indian Institute of Science and several IITs contribute to robotics and control research. Standards for industrial machinery and safety draw on the Bureau of Indian Standards. Engineers in this area design control systems, robotic cells, automation solutions and programmable logic controllers for factories and warehouses.

Fees for India: ₹734,000 (Indian Rupee), with instalments and employer sponsorship available.

Relevant bodies in India

  • Bureau of Indian Standards (BIS)
  • Indian Institute of Science (IISc)
  • Indian Institute of Technology (IIT) robotics research groups
  • Automation and Robotics Industry associations

Typical roles

  • Robotics Engineer
  • Control Systems Engineer
  • Automation Engineer
  • PLC Programmer

Questions from India

Is there a professional body in India that recognises robotics and automation engineers?

Robotics in India has no separate statutory title. The Institution of Engineers (India) is the main general engineering body, and technical standards come from the Bureau of Indian Standards. SEIUM's qualification is private and not accredited by any national body, so recognition rests with employers and the relevant body.

Which employers in India hire robotics and automation engineers?

Automotive plants, electronics manufacturers, factory automation suppliers, logistics firms, and robotics startups are typical employers. Hiring focuses on skills and project experience. The qualification can support a profile, but employers decide how much it counts and no outcome is guaranteed.

Can I study robotics online from India while working, and what language?

Yes, the programme is 100% online, so you can study from anywhere in India without a student visa and fit it around work. It is taught in English, so you need a reasonable level of the language. Each student has an assigned technical tutor, fees can be paid in instalments, and employer sponsorship is possible.

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Learning outcomes

What you will be able to do

01

Apply Good Manufacturing Practice to automation.

02

Validate computerised systems in line with GAMP 5.

03

Ensure data integrity according to ALCOA+.

04

Automate bioprocesses and batch operations.

05

Design automation for sterile manufacturing.

06

Implement process analytical technology.

07

Implement medicinal product serialisation systems.

Profile

Who it's for

  • Pharmaceutical automation engineers looking to deepen their expertise in regulated environments.
  • GAMP validation specialists.
  • Bioprocess engineers.
  • Data integrity leads.
  • Pharmaceutical MES engineers.
  • Serialisation technicians.
  • Engineering or science graduates seeking to enter the pharmaceutical sector.
Standards & tools

What you'll work with

  • EudraLex Vol. 4 Annex 11 (computerised systems)
  • 21 CFR Part 11 (electronic records and signatures)
  • GAMP 5 (2nd ed.) (risk-based approach to GxP computerised systems)
  • EudraLex Vol. 4 Annex 1 (manufacture of sterile medicinal products)
  • ICH Q9(R1) (quality risk management)
  • ICH Q10 (pharmaceutical quality system)
  • ISO 14644-1:2015 (cleanroom classification)
  • Delegated Regulation (EU) 2016/161 (safety features on medicinal product packaging)
  • Emerson DeltaV
  • Siemens SIMATIC PCS 7
  • Körber PAS-X
  • Rockwell PharmaSuite
  • SIMCA
Syllabus

12 modules · 1900 h

  1. 1.1The medicinal product value chain
  2. 1.2Chemical synthesis processes
  3. 1.3Upstream and downstream bioprocesses
  4. 1.4Solid and sterile dosage forms
  5. 1.5Specific features of regulated automation
  6. 1.6The AEMPS, EMA and FDA agencies
  7. 1.7Trends in continuous manufacturing
  8. 1.8Advanced therapies and their automation
  9. 1.9Pharmaceutical production indicators
  10. 1.10Case study: process map of a plant
  1. 2.1EU GMP principles
  2. 2.2EudraLex Volume 4
  3. 2.3Annex 1 on sterile manufacturing
  4. 2.4Annex 11 on computerised systems
  5. 2.521 CFR Part 11
  6. 2.621 CFR Part 211
  7. 2.7ICH Q10 quality system
  8. 2.8ICH Q9 risk management
  9. 2.9Inspections and observations
  10. 2.10Workshop: analysis of a warning letter
  1. 3.1GAMP 5 guide, second edition
  2. 3.2Software categories
  3. 3.3The V-model lifecycle
  4. 3.4User requirements specifications (URS)
  5. 3.5Functional and design specifications
  6. 3.6IQ, OQ and PQ qualification
  7. 3.7The FDA CSA approach
  8. 3.8Supplier management
  9. 3.9Validation report
  10. 3.10Practical exercise: URS-to-test traceability matrix
  1. 4.1ALCOA+ data principles
  2. 4.2Audit trails
  3. 4.3Electronic signatures and their linking
  4. 4.4User and privilege management
  5. 4.5Backup and archiving
  6. 4.6Data review
  7. 4.7MHRA and PIC/S guidance
  8. 4.8Data in hybrid systems
  9. 4.9Data integrity audit
  10. 4.10Case study: integrity assessment of a SCADA system
  1. 5.1Bioreactors and their instrumentation
  2. 5.2pH and dissolved oxygen control
  3. 5.3Feed control in fed-batch
  4. 5.4Automated purification chromatography
  5. 5.5Tangential flow filtration
  6. 5.6Single-use systems
  7. 5.7Continuous cell culture
  8. 5.8Process scale-up
  9. 5.9Online analytics
  10. 5.10Lab: dissolved oxygen control in a bioreactor
  1. 6.1ISA-88 in pharma
  2. 6.2Master and control recipes
  3. 6.3Electronic batch records (EBR)
  4. 6.4Batch–MES integration
  5. 6.5Exception management
  6. 6.6Review by exception
  7. 6.7Material traceability
  8. 6.8Automated material dispensing
  9. 6.9Equipment management
  10. 6.10Practical exercise: granulation recipe with ISA-88
  1. 7.1ISO 14644 cleanrooms
  2. 7.2Grade A to D classification
  3. 7.3Isolators and RABS
  4. 7.4Automated aseptic filling
  5. 7.5Environmental particle monitoring
  6. 7.6Sterilisation and freeze-drying
  7. 7.7Robotics in sterile environments
  8. 7.8Contamination control strategy
  9. 7.9Aseptic process simulation
  10. 7.10Case study: automation of a filling line
  1. 8.1The FDA PAT framework
  2. 8.2Quality by Design (ICH Q8)
  3. 8.3NIR and Raman spectroscopy
  4. 8.4Chemometric calibration models
  5. 8.5Real-time control
  6. 8.6Real-time release
  7. 8.7Continuous manufacturing (ICH Q13)
  8. 8.8Model lifecycle management
  9. 8.9Validation of PAT methods
  10. 8.10Lab: NIR content uniformity model
  1. 9.1Validated DCS and SCADA architectures
  2. 9.2Historians in GMP
  3. 9.3Alarm management systems
  4. 9.4Continuous environmental monitoring
  5. 9.5HVAC systems
  6. 9.6Purified water and water for injection
  7. 9.7Clean steam systems
  8. 9.8Change management
  9. 9.9Cybersecurity in GMP environments
  10. 9.10Workshop: change control in a validated system
  1. 10.1Falsified Medicines Directive
  2. 10.2Delegated Regulation (EU) 2016/161
  3. 10.3Unique identifier and DataMatrix
  4. 10.4Anti-tampering devices
  5. 10.5Tiered serialisation architecture
  6. 10.6The European EMVS repository
  7. 10.7DSCSA requirements in the USA
  8. 10.8Pack aggregation
  9. 10.9Validation of serialisation systems
  10. 10.10Practical exercise: serialisation line design
  1. 11.1Annual product review
  2. 11.2Deviations and CAPA
  3. 11.3Maintenance in GMP environments
  4. 11.4Calibration of critical instruments
  5. 11.5Quality indicators
  6. 11.6Manufacturing 4.0 in pharma
  7. 11.7Process digital twins
  8. 11.8Artificial intelligence in GMP
  9. 11.9Preparing for regulatory inspections
  10. 11.10Case study: investigation of a deviation
  1. 12.1Description of the pharmaceutical process
  2. 12.2Regulatory risk analysis
  3. 12.3Automation architecture
  4. 12.4Control strategy
  5. 12.5GAMP 5 validation plan
  6. 12.6Data integrity
  7. 12.7Traceability and serialisation
  8. 12.8Conclusions and implementation plan
  9. 12.9Master's Thesis report
  10. 12.10Master's Thesis: defence before a panel
Methodology, software & labs

How you'll learn

100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: you progress at your own pace within the intake, making it compatible with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Emerson DeltaV, Siemens SIMATIC PCS 7, Körber PAS-X, Rockwell PharmaSuite and SIMCA, in free, academic or evaluation versions. Exercises are based on real procedures for computerised system validation, bioreactor control and data integrity audits. Assessment is continuous by module, plus the final Master's Thesis.

Standards covered: EudraLex Vol. 4 Annex 11, 21 CFR Part 11, GAMP 5 (2nd ed.), EudraLex Vol. 4 Annex 1, ICH Q9(R1), ICH Q10, ISO 14644-1:2015, Delegated Regulation (EU) 2016/161.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of EudraLex Vol. 4 Annex 11, 21 CFR Part 11 and GAMP 5 (2nd ed.) applied to real cases, not as a theoretical annex.
Industry software:Emerson DeltaV, Siemens SIMATIC PCS 7, Körber PAS-X, Rockwell PharmaSuite and SIMCA, in free, academic or evaluation versions.
Master's Thesis with defence:An integrated automation, validation and serialisation project for a pharmaceutical process, defended before a panel.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Process and regulatory analysis
Describe the pharmaceutical process and analyse its regulatory risks.
Automation architecture
Design the automation architecture and control strategy for the process.
GAMP 5 validation plan
Draw up the validation plan with URS-to-test traceability.
Data integrity and serialisation
Define data integrity controls and the traceability and serialisation solution.
Master's Thesis
Integrate the work into a thesis with an implementation plan, defended before a panel.
Career opportunities

Where this takes you

Pharmaceutical automation engineerGAMP validation specialistBioprocess engineerData integrity leadPharmaceutical MES engineerSerialisation technician
Admissions & scholarships

Requirements

  • University degree in engineering, science or architecture, or equivalent demonstrable professional experience.
  • Internet connection and a computer capable of running the programme software.
  • English sufficient to read technical standards.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

Apply now Scholarships
FAQ

Frequently asked questions

The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.

You work with Emerson DeltaV, Siemens SIMATIC PCS 7, Körber PAS-X, Rockwell PharmaSuite and SIMCA, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.

A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.

Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.

A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the software and English sufficient to read technical standards.

Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.

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