Commissioning & Qualification –Area Lead, CQV

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: 15+ yrs.

Department: Commissioning and Qualification (USP / DSP / Clean utilities)

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

As Package Lead – C&Q, you’ll be working with highly skilled Senior Engineers and Engineers and still growing across Denmark and Indian team’s where 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 strong leadership qualities to lead a team of C&Q Engineers and understanding on stakeholders management at lead role.
• Have knowledge of process equipment’s systems
• Lead C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendor’s, and QA) of the project organization:
• 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
• Review work of project members in the quality work package.
• 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 (Preferred Competencies)

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:

• Project management skills regarding C&Q, facilitating board meetings to review status, timelines, quality, challenges, generating reports for steering group, understanding to evaluate risk and its mitigation strategies.
• Thrives in a fast-paced environment with many concurrent tasks.
• Need to train the team in performing the site activities and handling different stakeholders.
• 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 equipment’s (upstream and downstream and clean utilities) 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.
  
  
  

The Miles You’ve Walked (Education And Work Experience)

In all positions there are some things that are needed, and others a bonus. We believe 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.
• 15 + years experience performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment 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.

Sounds like something you’d like to do? If you’re ready to join our passion, let’s hear from you.

Deadline of application is 6th Feb 2025

Questions before applying? Please contact /

Please note we only accept applications submitted through our online recruitment system.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.

To ensure an efficient and fair recruitment process, we encourage you to refrain from adding a photo in your CV. At NNE, we commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We will invite to interviews on a running basis.

To learn more about us visit www.nne.com