Manager, C&q

Commissioning Qualification -Manager C Q 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 Main Roles Responsibilities As Manager - 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 be part of the Project team involved in making complex biopharma Large API facilities Driving the project with Science and Risk based Validation SRV concept Work very closely with our customers Extensive Travelling Involved Have strong leadership qualities to lead a team of C Q Engineers Leads and aligning with Multiple stakeholders Have knowledge of process equipment s systems To drive 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 Project execution Plan on C Q activities Having work experience on QMS based Project environment 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 experience in validation deliverables like URS design review P IDs FAT SAT IQ OQ PQs Test protocols and reports generation execution etc Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures 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 117-Nov-2025 Questions before applying Please 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 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