Advanced CQV Engineer

NNE; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

NNE is seeking an experienced professional for Commissioning and Qualification in Bangalore, India. You will join a dedicated team delivering large biopharma facilities, driving C&Q activities, and coordinating with multi-disciplinary groups to ensure compliant validation.

The role demands strong communication and a proactive, collaborative approach. Ideal candidates have 9–13 years in pharma commissioning and qualification, with ISPE C&Q and GAMP knowledge, and experience in handling URS,

Qualifications

• Experience in commissioning/qualification in FDA-regulated industry.
• Knowledge of ISPE C&Q guidance and GMP requirements.
• Familiarity with URS, P&IDs, FAT and SAT deliverables.

Responsibilities

• Lead commissioning and qualification activities for biopharma facilities.
• Coordinate multi-discipline teams to validate piping, instrumentation and utilities.
• Prepare and review commissioning protocols and qualification documentation.
• Ensure C&Q activities comply with GMP, GEP and regulatory standards.
• Interact with customers and ensure project interfaces are well managed.
• Support changes to scope and maintain alignment with project plans.

Skills

C&Q activities

GMP knowledge

PID understanding

Team collaboration

Communication skills

Education

Bachelor's or Master's in relevant field

Job description

Make your ability count at NNE

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

Why should you join us?

Whichever dream or focus you have; NNE offers exciting career opportunities in a truly passionate and high-powered working environment where you will join our Commissioning and Qualification team and will be part of Project Management team and Project Execution dedicated to deliver the largest Biopharmaceutical facility to our customers.

NNE have a work culture that’s shaped in value the employees for their unique skills, backgrounds, and perspectives which they bring to the table and work continuously in bringing out the best and, offering opportunities for development and promoting sustainable career opportunity within the company. As a Commissioning and Qualification team, you are going to handle different IT documentation platforms during the project lifecycle. For the right candidates there 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)

• 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 your energy is what impacts the effort we do as a team. As a Biotech person, 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 Work Experience)

• 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 by passion

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

Deadline of application is 30th Sep 2026

We will invite to interviews on a running basis.

To learn more about us visit www.nne.com