Bagsv%c3%a6rd Cleaning Area Process Manager Capi

Job description

Your impact begins here As Cleaning Area Process Manager, you will drive how cleaning is done across CMC Development, where our pilot plants make material for clinical trials under GMP. Acting as the functional anchor for cleaning standards, you will set direction, close compliance gaps and handle authority signals on behalf of CMC Development. Your work keeps our pilot plants inspection-ready and running with less downtime, so the clinical material that future treatments depend on is made safely, consistently and on time. What you’ll bring Deep cleaning expertise matters most in this role. We value breadth of experience across different companies and manufacturing environments as much as years in a role. A master’s degree in engineering, Life Sciences or a related field. Strong, hands-on expertise in cleaning processes in the pharmaceutical industry, including cleaning concepts and systems in a GMP environment. 5+ years of experience in manufacturing or production environments, with a focus on compliance and cleaning. Experience with CMC and clinical manufacturing, and a solid understanding of how clinical and commercial manufacturing environments differ. A thorough understanding of GMP and regulatory requirements in pharmaceutical manufacturing. Fluency in English. You bring proven project management experience and are comfortable facilitating cross-functional collaboration through complex discussions with clear priorities and technical credibility. You work collaboratively, involve the wider process group rather than solving things alone, and can design and deliver training that builds shared understanding of cleaning requirements. What you’ll do You will take ownership of the cleaning compliance agenda for CMC Development – from setting standards and handling authority feedback to improving how cleaning works on the shop floor. Facilitate the CMC Development cleaning process group, making sure cleaning activities meet internal requirements and applicable regulatory and GMP standards. Assess and act on cleaning compliance signals from authorities, audits and deviations: initiate investigations, coordinate responses and follow through on corrective and preventive actions (CAPA) with Production and QA. Represent CMC Development in the Novo Nordisk cleaning process group, and help translate agreed standards into clear local procedures, training and governance. Optimise cleaning methods, tools, acceptance criteria and execution with Production, QA and Maintenance – through better planning, standardisation and fit-for-purpose tools that reduce downtime. Spot recurring gaps, simplify ways of working and escalate high-risk or high-impact issues to senior management when needed. Develop training and onboarding materials, and give ongoing guidance so everyone involved applies cleaning requirements consistently. Support hands-on cleaning tasks in the Purification Pilot Plant and across API Pilots DK. Who you’ll work with You will join the Purification Pilot Plant within CMC Development, reporting to Senior Manager, Eva Synnestvedt Hansen. This is not a line management position; you will drive progress through subject-matter expertise, coordination and clear priorities rather than formal people management responsibility. Your closest partners will be the CMC Development Cleaning Process Group and colleagues across the CMC Pilots, together with Production, Quality Assurance and Maintenance. Beyond CMC Development, you will represent the area in the Novo Nordisk cleaning process group, aligning on shared standards and bringing best practice back to the pilot plants. You will connect global cleaning requirements with the realities of clinical manufacturing – helping different teams agree quickly, own decisions and move forward together. What you can expect here You will be trusted to take ownership of an important compliance area and to make your voice heard, both locally and in the Novo Nordisk cleaning process group. Working across the clinical pilot plants and alongside colleagues from the wider organisation, you will broaden your perspective and build new skills through cross-functional collaboration and practical experience.You will work in an environment where quality and patient safety are never compromised, and where standards are calibrated to the situation, so work keeps moving. You will be supported to perform at your best, with clear expectations and a culture that recognises results. What we offer At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage. Salary: For this role, the Annual Base Salary ranges from 651,000 DKK to 956,900 DKK, corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience. Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy her e . Start now Your impact begins today. If you are ready to bring deep cleaning expertise to the pilot plants where clinical material is made, apply for the Cleaning Area Process Manager role by 18th of October. For further information, please contact Senior Manager, Eva Synnestvedt Hansen at +45-30775324. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.