Makeyour ability count at NNE Weare experts in end-to-end pharma engineering, and our success is built on ourrelationships, both with our colleagues and our customers. If you want to workon projects shaping the future of sustainable and intelligent pharmafacilities, NNE is the place to be.
Whyshould you join us Whicheverdream or focus you have; NNE offers exciting career opportunities in a trulypassionate 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 that s 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: 10 -15 years Department Commissioningand Qualification (USP/ DSP / Clean utilities)
Howyou might spend your days (Main Roles & Responsibilities) As Advance CQV Engineer, you ll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian team swhere 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 high knowledge of process equipment s systems
Should have knowledge on terminologies of symbols used in PID.
Execute 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.
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 (PreferredCompetencies) 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 ateam. 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 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.
Themiles you ve walked (Education and Work Experience) In all positions there are some things that areneeded, and others a bonus. We believe these qualifications are needed for youto do well in this role:
Bachelor s or master s 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.
We reexperts bound by a noble cause and driven by passion
NNEis 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.
Soundslike something you d like to doIf you re ready to join ourpassion, let s hear from you.
Deadlineof application is 30th Jan 2025
Questionsnote we only accept applications submitted through our online recruitmentsystem.
You do not need to attach a cover letter to your application, but pleaseinclude a few sentences about why you are applying in your resume orCV.
Toensure an efficient and fair recruitment process, we encourage you to refrainfrom adding a photo in your CV. At NNE, we commit to an inclusiverecruitment process and equality of opportunity for all our jobapplicants.