Job Description

Make your talent 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. Work with us You will join our Project Quality Management area consisting highly skilled project employees. Specifically, you will be part of our commissioning & qualification team, consisting of 25 highly skilled Engineers, Lead engineers and Managers in Denmark and India, who are in charge of project quality in the largest execution projects in NNE. We engage and interact with a variety of stakeholders. Regardless of which of these many stakeholders we face, our ambition is to take a wingman position: Providing our stakeholders support in manner allowing them a feeling of collaboration and support. This requires a proactive mindset and approach to solving tasks and a high level of flexibility. What we can offer: You will be part of a highly competent and strong team that has solid experience in this niche. And you get the opportunity to learn from some of the best. Our PQM team works passionately and dedicated with their tasks. A team that is socially engaged and takes care of each other, but also goes the extra step for their projects. A busy and challenging project environment where the days are rarely the same. The opportunity to gain in-depth knowledge of Project Quality and Commissioning & Qualification which ultimately leads to a successful facility erection and operational. We create the framework for a good learning environment, and you help to fill them. How You Might Spend Your Days As a Senior PQM Engineer, you\'ll be working with a dynamic, multi-disciplinary team where your daily responsibilities include, but not limited to: Support and manage PQM activities like team management, leading a project package, collaboration with counterparts, cross-disciplinary reviews etc. Facilitate DERs (Design Reviews) with respect to system requirements by referring all the design documents. Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other Relevant Requirements: Bachelor\'s or master\'s degree in a relevant science, engineering, or pharmaceutical field 7 - 12 years\' experience performing commissioning and / or qualification activities in an FDA regulated industry. Should have ability to carry out risk assessment through various tools (FMEA/ FMECA/ HAZOP) etc. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, PS, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc. Should have experience of creating and updating of Traceability Matrix at various stages. Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently, while quickly building and nurturing a project team Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns Experience in planning / directing C&Q activities. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, or equivalent experience. Should have experience with Recent edition of Baseline Guide 5 (Commissioning & Qualification) Other Requirements: Expertise in Microsoft Word Excel and power point Excellent verbal and written English are required. Good team player Together we shape the future of pharma engineering. Think of how it would be going to work every day to help pharma manufacturers establish efficient, sustainable, and intelligent facilities that are essential for drug production worldwide. This is NNE. We are born and raised within pharma, which makes us more than a consultant engineering company. And if you share our values of innovating, taking initiative, and believing in teamwork, we invite you to join the passion! Sounds like something you\'d like to do If you\'re ready to unleash your potential, let\'s have a talk. Questions before applying Please contact Divya on [HIDDEN TEXT] Please note we only accept applications submitted through our online recruitment system. At NNE, we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. To learn more about us visit www.nne.com.

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