Advanced CQV Engineer

NNE


Job Location:

Bengaluru - India

Monthly Salary: Not Disclosed
Posted on: 5 hours ago
Vacancies: 1 Vacancy

Job Summary

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: Bangalore India.
Seniority: 9 -13 years
Department Commissioning and Qualification


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

As Advanced 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 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 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.
  • 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 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 equipments (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 youve 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:

  • Bachelors or masters 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.

Were 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. Iftheres one thing we all share its the passion for what we do. Together wedesign and build pharma facilities that are essential for millions of patientsall over the world.

Sounds like something youd like to do If youre ready to join our passionlets hear 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.

Toensure an efficient and fair recruitment process we encourage you to refrainfrom adding a photo in your 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


Required Experience:

IC

Make your ability count at NNEWe 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 y...