Lead CQV Engineer
Lead CQV Engineer
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: Lead CQV Engineer
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Commissioning & Qualification –Area Lead CQV
Make your ability count at NNE
We are experts in endtoend 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 highpowered 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:
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:
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:
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
Make your ability count at NNE
We are experts in endtoend 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 highpowered 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 followup on QAP planned C&Q activities
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 fastpaced 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.
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.
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
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Employment Type
Full Time
Key Skills
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