Rahway, NJ, 07065, USA
3 days ago
INTL Carlow, Ireland - Process Engineer, CMC Digitization
Job Description We are seeking a skilled Process Engineer to support our CMC digitization initiative for a leading pharmaceutical company in Dunboyne, Ireland. The ideal candidate will have extensive experience working in pharmaceutical manufacturing environments, experience with digital transformation, and knowledge of process knowledge management systems (PKM). Technical experience with Delta V, SAP, and MES systems, as well as expertise with pharmaceutical analytical instruments, tech transfer, and data management, is a requirement. This role will be critical in optimizing our manufacturing processes through digital knowledge transfer and automation, ensuring efficiency, compliance, and data integrity. Key Responsibilities: * Process Optimization: Analyze current manufacturing processes and identify opportunities for process & automation improvement. Implement best practices to enhance efficiency and quality. Analyze current manufacturing processes to identify opportunities for improvement through digital solutions. Develop and implement process optimization strategies to enhance efficiency, reduce waste, and ensure consistent product quality. * System Integration and Automation: Design, implement, and maintain automation systems using Delta V, SAP, and MES to support the CMC digitization initiative. Ensure seamless integration with existing processes and systems. * Tech Transfer: Facilitate technology transfer activities, ensuring the smooth transition of processes and data from R&D to manufacturing and site-to-site. * Data Management: Develop and implement data management strategies to ensure accurate, secure, and accessible data across all digitized processes. Support data collection, analysis, and reporting. * Project Collaboration: Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, IT, and Manufacturing, to ensure alignment and support for automation initiatives. * Compliance and Validation: Ensure all automation and digitization efforts comply with regulatory standards and quality requirements. Participate in validation and verification of automated systems. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements Minimum of 5 years of experience in process engineering within the pharmaceutical or biotechnology industry. Proven experience with digital transformation projects in a manufacturing environment Knowledge/Familiarity with process knowledge management- (process data digitally transferred from sending unit: qualified, version controlled, structured). Expertise in Delta V, SAP, and MES systems, with a proven track record of successful system integration and automation. Strong knowledge of tech transfer processes and data management strategies in a pharmaceutical context. Knowledge of international manufacturing and regulatory standards related to pharmaceutical products and substances Large molecule pharmaceutical process engineering experience Bachelor's degree in Chemical Engineering, or a related field. null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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