Senior MES Specialist

For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. Job Description Kite, a Gilead Company At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential. We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer. Department Description As Manufacturing Process Engineer you’ll be joining a team in which employees of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the Manager Process Engineering (Manufacturing Systems Support). You’ll be part of the Manufacturing Systems Support team (part of Manufacturing Technical Services) for our recently established manufacturing site in Hoofddorp (NL). In this role you will be part of a team responsible for deploying, maintaining and implementing changes in computerized systems in manufacturing (MES, LIMS, ERP etc) and plays a central role in the digitalization of manufacturing in Kite’s commercial manufacturing site, producing autologous T-cell therapy products. The team also takes care of training, support and improvement projects around aforementioned systems. Your responsibilities MES EBR editor Understand the process and user requirements driven by process maps / flows in preparation for developing or updating EBR designs Convert process and user requirements into specific EBR designs and design elements (Basic Functions, Basic Operations, complex Formulas and ERP integration) Drive and support EBR design verification activities (lifecycle documentation generation, configuration/design testing and qualification) Manage EBR approval and retirement workflows to ensure correct record state Generate and maintain system life cycle documentation such as User Requirements Specifications, Configuration Specifications, and Functional/Design Specifications Lead design reviews and EBR version cut-overs with peers and a cross-functional stakeholder team MES Key user Lead MES projects and change implementations Serve as part of the support group for MES users by analyzing and resolving issues and providing necessary instructions Escalate business continuity impacting issues to Process Owner and respective tier Support EBR impact assessments based on the manufacturing/business process requirements and changes Identify and document MES (business) and manufacturing process requirements. Identify and document improvement proposals Support Training materials development. Create and update Process SOPs, MES SOPs, and MES work instructions Provide input during design reviews of new and updated MBRs Provide input for lifecycle documentation generation and updates Organize and manage testing, qualification and review activities Keep knowledge up to date with MES application among users and stakeholders Participate in audits and inspections acting as MES subject matter expert Your profile Education Bachelor’s degree or equivalent experience Knowledge and Experience 5 years’ relevant (process engineer/MES specialist) experience within a Pharmaceutical/GMP Manufacturing site Excellent knowledge of manufacturing processes Good experience with supporting users Experience with writing and execution of CSV documentation / protocols Experience in identifying opportunities for improvement, best practice and standardization Experience with GMP in a pharmaceutical environment, preferable cell therapy Experience with quality systems (change controls, deviations and CAPAs) in a pharmaceutical environment Knowledge of PAS-X version 3 is a plus Experience with SQL and XML coding with respect to MES is a plus Knowledge of the MES database and data elements as part of querying and reporting is a plus Experience with managing projects is preferred Good interpersonal skills Personal skills Ability to take the lead and drive projects and changes Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities Ability to function efficiently and independently in a changing environment Self-motivated, well-organized and willing to accept temporary responsibilities outside of initial job description Collaborate well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel Ability to think critically and demonstrated troubleshooting and problem-solving skills Good English language skills Additional Requirements Able to work on-Call / On stand-by outside office hours As part of our recruitment process, you will be asked to complete a short 20-minute online Occupational Personality Questionnaire (OPQ) and/or a capability test. Apply now! Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Change The World With Us Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority. The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.