Advanced CQV Engineer

NNE Inc.; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

NNE is seeking an Advanced Engineer – C&Q to join its Commissioning and Qualification team in Bangalore. You will work with senior engineers, drive SRV-based validation concepts, and collaborate with Denmark and Indian teams to deliver scalable biopharma facilities.

Responsibilities include coordinating commissioning of process and utility systems, generating validation deliverables (URS, P&IDs, FAT, SAT), ensuring GMP/GEP compliance, and guiding smaller cross-disciplinary projects while

Qualifications

• Bachelor’s or master’s degree in a relevant science, engineering, or pharmaceutical field.
• Experience in performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment and utility qualification.
• Should have knowledge with ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.

Responsibilities

• Drive projects with SRV concept and ensure alignment with customers.
• Coordinate commissioning of Process & Utility systems with multi-discipline teams.
• Generate validation deliverables such as URS, P&IDs, FAT, SAT.
• Ensure C&Q documentation complies with GMP and GEP.
• Collaborate with Denmark and Indian teams and support project management.
• Conduct C&Q activities in cross-disciplinary teams.

Skills

Project coordination

Communication skills

Independent work

Subject matter knowledge

Team collaboration

Education

Bachelor’s or master’s degree

Job description

Make your ability count at NNE

We are experts in end-to-end pharma engineering, and our success is built onour relationships, both with our colleagues and our customers. If you want towork on projects shaping the future of sustainable and intelligent pharmafacilities, NNE is the place to be.

Why should you join us?

Whichever dream or focus you have; NNE offers exciting career opportunities ina truly passionate and high-powered working environment where you will join ourCommissioning and Qualification team and will be part of Project Managementteam and Project Execution dedicated to deliver the largest Biopharmaceuticalfacility to our customers. NNEhave a work culture that’s shaped in value the employees for their uniqueskills, backgrounds, and perspectives which they bring to the table and workcontinuously in bringing out the best and, offering opportunities fordevelopment and promoting sustainable career opportunity within the company. Asa Commissioning and Qualification team, you are going to handle different ITdocumentation platforms during the project lifecycle. For the right candidatesthere will be possibilities for business travels or relocation to Denmark.

Location: Bangalore, India.

Seniority: 9 -13 years

Department Commissioning and Qualification

How you might spend your days (Main Roles & Responsibilities)

As Advanced Engineer – C&Q, you’ll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian team’swhere you’ll:

• Would like to help making complex biopharma facilities more sustainable.
• Driving the project with Science and Risk based Validation (SRV) concept.
• Work very closely with our customers.
• Have knowledge of commissioning of Process & Utility systems and collaborate with multi-discipline teams to integrate piping distribution, instrumentation and automation services, facilitate and ensure right commissioning across the project.
• Good technical knowledge on Piping codes and standards.
• Should have knowledge on terminologies of symbols used in PID.
• Perform C&Q activities in smaller cross-disciplinary teams:
• Align quality and validation concept with customer’s quality system & validation concept
• Define scope of C&Q activities in project and scope of work within quality work package incl. relevant C&Q activities
• Ensure changes to scope are brought to the attention of Project Management.
• Ensure interfaces to and coordination with other disciplines and compliance with codes, regulations and relevant Procedures.
• Ensure right level of commissioning processes so as to have smooth qualification phases
• Generate validation deliverables like commissioning , protocols etc
• Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
• Conduct follow-up on QAP planned C&Q activities

Who you are

We care about who you are as a person. In the end, how you work, and yourenergy is what impacts the effort we do as a team. As aBiotechperson, you

Experience in executing pre-commissioning activities like walkdown ,mechanical completion, partial stat-up of a distribution system, etc

• Should have experience in clean utility qualification
• Hands on experience in C&Q activities of process equipment’s (upstream and downstream and CIP) in DS facility qualification
• Should have experience in validation deliverables like URS, P&IDs, FAT, SAT, generation & execution, etc
• Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures.
• Responsible for operational or administrative deliverables where output is complex.
• Can work independently, or alternatively project work in small projects
• Expected to support more senior staff in parts of larger processes or project on project deliverables
• Expected to adapt procedures, processes, tools, equipment, or techniques to accomplish the correct output of specific assigned tasks.
• Expected to, take initiative, prioritize, and plan the work to reach deadlines
• Make operational decisions through a choice between known alternatives.
• + Demonstrates subject matter knowledge.

The miles you’ve walked (Education and WorkExperience)

In all positions there are some things that are needed, and others a bonus. Webelieve these qualifications are needed for you to do well in this role:

• Bachelor’s or master’s degree in a relevant science, engineering, or pharmaceutical field.
• Experience in performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment and utility qualification.
• Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.

We’re experts bound by a noble cause and driven bypassion

NNE is short for Novo Nordisk Engineering. And for all of us who work here, NNEmeans so much more. Some of us are driven by working on highly complex projectstogether with other leading experts. Others are inspired by a work environmentwith flat hierarchy and flexible conditions. And some love the fact that theywork for a world leading engineering consultancy within the pharma industry. Ifthere's one thing, we all share, it's the passion for what we do. Together wedesign and build pharma facilities that are essential for millions of patientsall over the world.

Deadline of application is 30th Sep 2026

At NNE, we commit to an inclusiverecruitment process and equality of opportunity for all our jobapplicants.

Wewill invite to interviews on a running basis.

Tolearn more about us visit www.nne.com