Full Time Contract Title: CSV Engineer (Global) Location: Remote Length of Contract: 6 months. Company Description: Our client is a global biotech drug manufacturer located in the USA and Germany and is currently expanding its manufacturing facilities. The manufacturing sites are state-of-the-art aseptic processing facilities equipped with advanced technology and equipment to ensure the safety and quality of the products manufactured following USA and Europe regulations. They have the ability to produce a wide range of biologics, including monoclonal antibodies, recombinant proteins, and other complex therapies. Position Description: The CSV Engineer will be responsible for performing software installation, configuration, and computer system validations within the client USA and Europe manufacturing sites. The CSV Engineer will work to ensure all systems operate in full compliance with applicable USA and European regulations and maintain consistent functionality throughout their operational life. Responsibilities: + Perform computer system validation, particularly for BMRAM, ServiceNow systems, and Citrix/AD Migration + Author and execute computer system validation and qualification documents, including defining test cases and writing test scripts. + Manage system administration and access controls. + Collaborate with internal functions and external vendors regarding qualification and validation issues. + Define and implement IT Infrastructure strategies, including backup procedures. + Manage system upgrades and ensure smooth transitions. + Conduct periodic reviews and system audit trail assessments. + Create and maintain equipment operation procedures and participate in data integrity initiatives related to computer systems. Qualifications: + Proven experience in computer system validation (CSV). + Strong knowledge of regulatory requirements (e.g., USA FDA, 21 CFR Part 11, GxP and the EMA). + Experience writing and executing validation documentation, including test cases and test scripts. + Familiarity with system administration, access management, and security protocols. + Knowledge of IT infrastructure and backup strategy development. + Ability to manage system upgrades and conduct periodic system reviews and audits. + Strong understanding of data integrity principles and secure software configuration practices. + Knowledge of Veeva application. + Excelent presentation skills and English speaking and writing is a must. Education & Certifications: Eight years of experience in IT and GxP compliance performing similar tasks and a bachelor's degree in engineering (highly desirable), computer science, or a related field. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.