About the Company

PharmNXT Biotech is an innovation-driven biotechnology company, specializing in end-to-end bioprocess solutions for the biopharmaceutical industry. Through our state-of-the-art PharmNXTEkuse manufacturing facility, we design and manufacture single-use bioprocess systems, containment solutions, and advanced hardware technologies for biologics manufacturing. Guided by our vision of "Make in India for the World,"

we deliver high-quality, cost-effective solutions that support the production of life-saving therapies for customers across the globe.

You can learn more about us here: https://www.pharmnxtbiotech.com .

About the Role The Senior Process Engineer is a hands-on technical role that spans design, product development, customer engagement and project ownership for bioprocess equipments.

Qualifications

- 5 - 10 years of Experience in Design & Process in Single Use Technology
- Master’s or Bachelor’s degree in Biotechnology, Bioprocess Technology, Chemical Engineering, or equivalent field

Required Skills

- Single-Use Technology & Manufacturing
- Experience in Single use Manufacturing, Manifold assembly, Single Use Bags
- Experience in Single use System Qualifications
- Bioprocess & Process Systems
- Robust knowledge of bioprocess engineering and upstream/downstream process systems.
- Hands-on experience with fermentation, media/buffer preparation, chromatography, TFF, filtration and Filling systems.
- Engineering Documentation & Equipment Design
- Proficiency in preparation and review of engineering documents such as PFDs, P&IDs;, datasheets, layouts, and process calculations.
- Knowledge of equipment sizing and selection and process system integration

Responsibilities Project Management & Execution

- Lead and execute projects across the complete project life cycle, including planning, process engineering, detailed design review, procurement coordination, execution, testing, delivery, commissioning, and project closeout, ensuring achievement of KPI targets, timelines, budget, quality,



and customer requirements.
- Take complete technical ownership of medium to large-scale bioprocess projects from enquiry stage through final handover, ensuring accurate scope definition, optimized process solutions, and effective risk management.
- Monitor project schedules, milestones, technical risks, change controls, and project costs, and proactively implement corrective actions to maintain overall project performance and profitability.
- Ensure systems are designed, manufactured, tested, documented, and delivered in accordance with contractual specifications, quality standards, regulatory expectations, project schedules, and commercial commitments.

Bioprocess Engineering & Technical Expertise

- Analyse customer processes and process requirements for engineered systems used in upstream and downstream bioprocess applications including fermentation, media/buffer preparation, harvest systems, chromatography, tangential flow filtration, depth filtration, viral inactivation, CIP/SIP systems, and other related bioprocess technologies to develop optimized and integrated process solutions.
- Review and finalize equipment sizing, utility requirements, process calculations, and system integration philosophy to ensure reliable and efficient system performance.

Engineering Design & Technical Documentation

- Prepare, review, approve, and manage all project-related engineering and technical documents including PFDs, P&IDs;, layouts, process calculations, equipment datasheets, specifications, design qualifications, protocols, validation documents, SOPs, and technical reports.




- Review process designs and engineering deliverables to ensure compliance with customer URS, GMP guidelines, applicable industry standards, and internal engineering practices.
- Lead and support FAT, SAT, commissioning, IOQ, troubleshooting, performance trials, and customer acceptance activities at vendor and customer sites whenever required.

Customer & Stakeholder & Team Management

- Travel to customer sites for project execution, commissioning support, technical discussions, process troubleshooting, optimization activities, and customer coordination.
- Coordinate effectively with customers, vendors, consultants, and cross-functional internal departments including design, automation, electrical, manufacturing, procurement, QA/QC, validation, and service teams for successful project execution.
- Lead technical discussions with customers and consultants during project execution, design reviews, troubleshooting, and change management activities.
- Provide technical leadership and mentoring process engineers and project team members, ensuring adherence to engineering standards, best practices, and project procedures.

Pre-Sales & Business Development

- Support business development and pre-sales activities by preparing technical proposals, compliance statements, process concepts, equipment sizing, technical presentations, cost optimization inputs, and participating in customer technical clarification meetings.

Project Reporting & Documentation

- Prepare and present periodic project reviews, technical updates, MOMs, progress reports, risk assessments, and project closure documentation to management and customers.
- Quality, Safety & Compliance
- Ensure compliance with company procedures, safety practices, GMP requirements, and applicable regulatory and engineering standards throughout project execution.
- Support continuous improvement initiatives related to engineering practices, documentation standards, project execution methodologies, and process optimization.

📌 Sr. Process Engineer (Pune)
🏢 PharmNXT Biotech
📍 Pune