Merck Senior Specialist, Business & Technical Analysis in De Soto, Kansas
Our company is a leading global biopharmaceutical company. For more than a century, our company has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.
Today, our company continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including (Human Immunodeficiency Virus ) HIV and Ebola.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
We are looking for a Senior Specialist, Business & Technical Analysis for our De Soto, KS location to support the Animal Health Information Technology department and strengthen our Lab Informatics capabilities. Communicate with regulatory authorities around the globe, including Organization for Economic Cooperation and Development (OECD) and Food and Drug Administration (FDA), to harmonize Information Technology (IT) lab processes in compliance with global regulations. Foster alignment of IT standards and procedures between our company's European and US sites, addressing regional differences between procedures and standards in order to uphold Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Ensure that the Lab IT environment is operated according to our company's corporate standards and that our company's SDLC is implemented and followed. Manage the integration of laboratory instrumentation with enterprise software systems through the deployment of lab specific integration technologies. Implement laboratory information management systems (LIMS) and inventory systems, Electronic Lab Notebook (ELN), Scientific Data Management Systems (SDMS), Raw Data Archiving solutions, and more.
Daily job duties include the following:
Developing Research and Lab IT architecture and system roadmap, aligning IT direction to the business strategy and goals; working with the business to develop business goals and associated short-term and long-term roadmaps that will advance business information and technology needs (20%);
Project Management and Business analysis for LIMS, including sampling inventory, raw data archiving, and implementing platforms such as ELN (20%);
Providing laboratory support, including providing tools and guidance to employees using lab computerized systems, and leveraging our company's SDLC standards (20%);
Supporting laboratory IT processes, including lab support model optimization and harmonization. Developing tools and risk based processes to ensure IT compliance and IT GxP permanent inspection readiness. Supporting external Health Authority Regulated audits (20%);
Supporting service organization, training, and development (10%); and
Technology Watch regarding Lab Computerized systems and platforms (10%).
Bachelor’s degree in Information Systems, IT management or related field.
5 years of experience supervising computerized lab systems for multinational health sciences industry including the following: audits and GxP inspections; configuring lab IT systems and platform solutions to meet business and regulatory requirements; handling system-wide upgraded; implementing global backup and recovery solutions; implementing Electronic Lab Notebook with interfaces to LIMS system; working with CSV (Computer System Validation) and international regulatory compliance (GLP and GMP); developing technical guidelines to ensure data integrity; and working with Openlab, ELN, and Empower.
Will also accept a MS degree and 3 years of stated experience.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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Requisition ID: R100750