Senior CQV Engineer

Commissioning & Qualification Senior CQV Engineer
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 thats 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: BangaloreIndia
Seniority: 13 Yrs
Department Commissioning and Qualification (USP / DSP / ClP)

How you might spend your days (Main Roles & Responsibilities)
As Senior Engineer C&Q youll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian teamswhere youll:
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 high knowledge of process equipments systems
• Should have knowledge on terminologies of symbols used in PID.
• Execute C&Q activities with multiple stakeholders like (Engineering responsible Design consultant Vendors and QA) of the project organization
• Align quality and validation concept with customers 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.
• Generate validation deliverables like IQ OQ PQ protocols and reports etc.
• Act as Smarter Execution consultant for Project Members.
• 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 the end how you work and yourenergy is what impacts the effort we do as a team. As aBiotechpersonyou:

• Thrives in a fast-paced environment with many concurrent tasks.
• Support onsite and offsite activities such as: FATs SATs IOQ and PQ Executions and System Walkdowns.
• Hands on experience in planning / directing C&Q activities of process equipments (upstream and downstream and CIP) in DS facility qualification
• Should have hands on experience in validation deliverables like URS design review P&IDs FAT SAT IQ OQ PQs protocols and reports generation & execution etc.
• Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures.
• Responsible for delivering operational or administrative work where issues are more complex.
• Work is performed entirely independent and might involve leading processes or parts of a larger process.
• Reviews work and ensures coaching and training of more junior colleagues in own discipline.
• Demonstrates subject matter expertise.
• Work requires the ability to handle complex challenges and apply specialist knowledge when adapting solutions.
• Expected to identify better practice and improve procedures processes tools equipment or techniques.
• Requires some industry specific knowledge and understanding.
• The work requires broad theoretical knowledge and business experience.
• Expected to plan and prioritize own work in a complex and changing environment (VUCA)
• Makes decisions under conditions of uncertainty.
• Demonstrates subject matter expertise.
• Proven knowledge of business processes and operating procedures within own functional area or knowledge domain.
• Ability to coach and train more junior colleagues.

The miles youve walked
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:

• Bachelors or masters degree in a relevant science engineering or pharmaceutical field.
• Experience performing commissioning and / or qualification activities in an FDA regulated industry.
• Have hands on experience in validation deliverables like URS design review P&IDs FAT SAT IQ OQ PQs protocols and reports generation & execution etc.
• 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.

Were experts bound by a noble cause and driven bypassion
NNE is short for Novo Nordisk for all of us who work here NNE means so much more. Some of us are drivenby working on highly complex projects together with other leading are inspired by a work environment with flat hierarchy and flexibleconditions. And some love the fact that they work for a world leadingengineering consultancy within the pharma industry. If theres one thing weall share its the passion for what we do. Together we design and build pharmafacilities that are essential for millions of patients all over the world.

Soundslike something youd like to do If youre ready to join our passion letshear from you.

Deadline of application is 31st July 2026

Questionsbefore applyingPlease

Pleasenote we only accept applications submitted through our online recruitmentsystem.
Youdo not need to attach a cover letter to your application but please include afew sentences about why you are applying in your resume or CV.
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Wewill invite to interviews on a running basis.
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Required Experience:

Senior IC