Senior Process Engineer USP

Job Description - Senior Process Engineer USP (2406180182W) Senior Process Engineer USP - 2406180182W Description Janssen Biologics B.V., a member of the Johnson & Johnson's Family of Companies is recruiting for a Senior Process Engineer to be based in Leiden, Netherlands! This is a fixed duration role. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  https://www.jnj.com/. Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products. One of the key focus area's for JNJ in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases. At the Johnson & Johnson site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Gene Therapy Facility (GTF). Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients? Then this is your job! Job Summary: You will become part of the Process, Technology and Projects (PTP) teamand strengthen our department with knowledge and expertise of the Upstream process. This vacancy is for a Subject Matter Expert (SME) on the Upstream process. You are the process owner and as such have different roles and responsibilities; technology transfers / new product introductions (NPI), base business supporter and project member or - lead. The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Drug Product, Project management, process excellence and safety. Together, we ensure to have safe, lean, robust, manufacturable, and compliant processes. Close collaboration within and outside GTF is vital to ensure that the overall GTF goals can be achieved. The other two departments in the GTF are: The Operations Department is responsible for timely, compliant, safe and first-time right manufacturing and delivery of the planned batches The system owners in the Center of Expertise (CoE) ensure that our production equipment and single use flow paths in the GTF are operational, safe, compliant, robust and ready for the future. The departments you work closely with outside GTF are: The Gene Therapy development department of Johnson & Johnson is based in the US (Malvern) and responsible for the tech transfer to our site. You will be the main interface and point of contact for them. MSAT are the product owners as soon as the product will be commercially manufactured MAKE Asset Management (MAM) is responsible for equipment delivery and CAPEX for the tech transfer projects Key Responsibilities: The process engineers in the team are process owners and have two major roles: 1. Ensure that new processes and enabling technologies are smoothly implemented into the GTF, using solid project management tools and extensive (bio)technical knowledge. PTP employees are key members or leads during Technology Transfers / New Product Introductions and in projects involving process changes. This involves: Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely. Ensure that the (development) knowledge is accurately transferred into the process and operational documentation. 2. Support existing processes and technologies by investigating and assessing major process deviations, identifying and implementing process improvements, and analyzing critical process data. During the launch, grow and commercial phases the PTP process engineers are process owners and subject matter experts (SMEs) on the previously introduced processes. This involves: Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely. Ensure that the (development) knowledge is accurately transferred into the process and operational documentation. Support production of cGMP batches for existing processes in the GTF in the area of upstream processing. Initiate and handle compliance records (change control, CAPA, deviations), including investigation of major deviations for potential product impact, root cause investigations of complex deviations, evaluation of changes prior to implementation and data gathered post implementation to show that the change had the desired effect. have the overview and knowledge of the status of the process. Identify, and conceptualize and implement (process) improvements. Lead or are key member in projects involving process changes and implementation of (enabling) technologies, including Digital Technologies. Are the interface with the product owners (MSAT or R&D), regulatory and value chain departments and work with MAKE Asset Management (MAM). If you meet the following Job requirements, we would like to hear from YOU: Qualifications Education: Bachelor's degree or equivalent experience is required/ Master's degree in Biotechnology, Biochemistry, Biomedicine, process technology is preferred. Experience and Skills: Required: A minimum 2 years of relevant professional experience is required Proven experience in a biotechnology or biopharmaceutical industry environment, in a cGMP environment and with EHSS standards. (In depth,) up-to-date knowledge of bio processing principles typically used in Upstream processing using disposable technologies. Excellent communication in English (verbal and written) You are proven resilient. You can deal with challenges, changes and unexpected setbacks in a positive and meaningful way. Preferred: Good understanding of regulatory requirements and industry guidelines specific for the drug product industry (e.g. GMP, Annex 1, etc.). Collaboration: Is assertive or adaptable at the right times and to the right degree. Actively connects with peers/colleagues/stakeholders/external partners and makes use of these connections within the organization. Resilient: Can adapt and remain calm and positive in a dynamic and agile environment and can effectively manage changes. Celebrates successes and embraces failures together. Analytical thinking: Successful in identifying, determining, and solving problems. Identifies areas for improvement having high impact and proposes a solution. Other: May required up to 10% travel What we offer: Janssen Biologics in Leiden, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Advance Therapeutic Medicinal Products. At Janssen Biologics, enthusiastic people are working together in a high-performance culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and contribute to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark! Your development is key to us, and we consider it our day-to-day responsibility. We believe we can make a difference together and take your career seriously. Through on-the-job and development trainings, assignment to projects and programs, we are committed to your personal and professional growth. Via multiple employee benefits, our company offers support for you and your family now and in the future. In addition, there are many employee benefits such as flexible working from home arrangements and 36 days holidays (based on full-time employment). Our Commitment to Diversity, Equity, & Inclusion: For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our  Credo . We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"! Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit  www.careers.jnj.com . Primary Location Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement. If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. 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