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 Bioprocess CQV Engineer is responsible for ensuring product quality, manufacturing process compliance, equipment qualification, and validation activities across bioprocess equipment manufacturing operations. The role supports the design, fabrication, testing, qualification, and delivery of GMP-compliant bioprocess equipment while ensuring adherence to quality standards, regulatory requirements, and customer specifications.

The position requires strong technical knowledge of bioprocess equipment, single-use systems, automation, and qualification practices, with hands-on involvement from FAT through site commissioning and final performance qualification.

Qualifications

- Education: Bachelor's or Master's degree in: Biotechnology, Mechanical Engineering, Chemical Engineering, Bioprocess Engineering, Instrumentation Engineering, Life Sciences.
- Experience: 5 to 10 years of experience in Quality Assurance, Validation, Qualification, or Manufacturing Quality within: Bioprocess Equipment Manufacturing, Biotechnology Industry, Life Science Engineering Companies.

Responsibilities

Quality Management Systems

- Maintain and enhance Quality Management System (QMS) processes in compliance with ISO 9001 and applicable GMP requirements.




- Manage deviations, non-conformances, CAPA, change controls, and risk assessments.
- Review, and approve SOPs, protocols, work instructions, and quality records.
- Ensure compliance with customer quality requirements and internal standards.
- Support supplier qualification.
- Ensure all documents are completed in accordance with Good Documentation Practices (GDP).

Equipment Design & Qualification

- Participate / support in qualification and validation activities for bioprocess equipment, including – URS, DQ, FAT, SAT, IQ, OQ, PQ.
- Review qualification protocols, reports, and traceability documentation.
- Support validation of automated control systems and software platforms.
- Ensure proper calibration and qualification of manufacturing and testing equipment.
- Provide quality oversight during fabrication, assembly, welding, polishing, Weld log, welder qualification, Isometric drawings, Boroscopy, Hydro test and other testing activities.
- Review manufacturing records and quality documentation.
- Ensure compliance with ASME BPE, GAMP 5, ASTM, cGMP, 21 CFR part 11 and customer requirements where applicable.
- Participate in design reviews to ensure manufacturability and compliance.
- Participate in customer FAT/SAT and ensure all punch points and deviations are appropriately assessed, documented, and closed.
- Identify opportunities to improve manufacturing quality, efficiency, and process robustness.
- Conduct root cause investigations using tools such as: 5 Why Analysis,



Fishbone Diagram, FMEA, Risk Assessments.
- Support customer audits, supplier audits, and qualification visits.
- Address audit observations and customer complaints.
- Ensure complete and accurate turnover packages.
- Work closely with Engineering, Manufacturing, Automation, Project Management, Procurement, and Service teams.

Required Skills

- Strong understanding of CQV lifecycle and risk-based qualification approaches.
- Strong knowledge of IQ/OQ/PQ qualification methodology.
- Understanding of bioprocess equipment such as: Bioreactors, Fermenters, Chromatography Systems, Filtration Systems, Single-Use Technologies.
- Understanding of instrumentation, sensors, control valves, pumps, and process control systems. Review of components certificates, calibration certificates, MOC certificates, etc.
- Experience with FAT and SAT execution.
- Familiarity with cGMP, GDP requirements and validation documentation.
- Knowledge of ASME BPE, ASTM standards and hygienic equipment design principles.
- Knowledge of FMEA, risk assessment, deviation management, and CAPA.
- Ability to work effectively in cross-functional and customer-facing environments.
- Strong troubleshooting and root cause analysis skills.
- Strong attention to detail and quality mindset.
- Proficiency in MS Office, including Excel, Word, and PowerPoint.
- Robust technical writing and documentation skills.
- Willingness to travel to supplier and customer sites for FAT, SAT, commissioning, and qualification activities.
- A professional with hands-on experience in bioprocess equipment manufacturing, capable of bridging engineering, quality, and validation functions, while ensuring that equipment supplied to biotech and pharmaceutical clients meets GMP, validation, and customer compliance requirements.

📌 Bioprocess CQV Engineer (Pune)
🏢 PharmNXT Biotech
📍 Pune