Senior Engineer, CQV

Commissioning & Qualification Sr.
Engineer ,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; 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: 10 -15 years.
Department Commissioning and Qualification (USP / DSP / Clean utilities).
How you might spend your days (Main Roles & Responsibilities).
As Senior Engineer C&Q, youll be working with highly skilled Senior Engineers and Engineers and still growing across Denmark and Indian teams where 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 (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: 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 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 Youve 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: Bachelors or masters degree in a relevant science, engineering, or pharmaceutical field.
10-15 years' 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 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 youd like to doIf youre ready to join our passion, lets hear from you.
Deadline of application is 28th Nov 2024.
Questions before applyingPlease contact PVYN@nne com.
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.