Engineer – Bioprocess

Job Summary

We are seeking a skilled and detail-oriented Bioprocess Engineer with 2–4 years of experience to join our engineering team. The ideal candidate will be responsible for reviewing customer requirements, preparing technical documentation, coordinating with internal and external stakeholders, and supporting validation activities including FAT/SAT and simulation testing.

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Key Responsibilities

1. Engineering Documentation & Planning

• Review and plan based on customer-approved URS and Technical Offer.
• Study approved P&ID and develop an execution plan.
• Prepare Bill of Materials (BOM) as per approved P&ID.
• Prepare, follow up, and close queries and deviations from the approved URS, if any.

2. Functional Documentation & Specifications

• Prepare and finalize:
  • Valve Matrix (VM)
  • Functional Specification (FS)
  • Equipment Modules (EM)
• Prepare and close associated documents as annexures to FS.
• Review, finalize, and submit FS, VM, annexures, and operational manuals.

3. Coordination & Technical Validation

• Coordinate with third-party aggregators, if required, ensuring complete and error-free deliverables.
• Conduct, document, and finalize simulation testing with third-party aggregators (if applicable).
• Update and finalize the development program based on simulation results with the Automation team.

4. Testing & Qualification Activities

• Conduct and close bench testing with the Automation team.
• Document and comply with results/findings of bench tests.
• Participate in and close:
  • Pre-FAT activities
  • FAT (Factory Acceptance Testing)
  • SAT (Site Acceptance Testing)
• Document findings and ensure closure of all observations during Pre-FAT, FAT, and SAT.

5. Customer & Site Support

• Provide online support and, if required, visit customer sites for technical assistance and issue resolution.

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Required Skills & Competencies

• Strong understanding of bioprocess systems and automation concepts
• Proficiency in interpreting P&ID diagrams
• Experience in preparing FS, VM, and technical documentation
• Familiarity with FAT, SAT, and validation processes
• Excellent coordination and communication skills
• Strong analytical and problem-solving abilities
• Ability to manage documentation and meet project timelines