Engineer I

Summary: cGMP Consulting Inc. specializes in providing validation, qualification, and compliance services to the life sciences industry. They are seeking an Engineer I to support engineering activities for equipment and processes in a GMP-compliant manufacturing environment, offering hands-on experience and the opportunity to work with limited supervision. Responsibilities: - Assist in the setup, testing, and daily operation of new processes, equipment and systems in collaboration with Engineering teams - Perform validation and qualification tasks for equipment, utilities, cleaning procedures, computer systems, and/or new products - Execute validation/qualification studies for utilities, equipment, cleaning processes, computer systems, and new products, including protocol preparation and final report documentation - Support deviation investigations by collecting data, writing reports, and performing supplemental qualification activities - Author SOP updates and revisions related to processes, equipment and system modifications - Operate and program instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers, incubators) - Collaborate with SMEs to identify and resolve technical challenges effectively - Maintain compliance with company policies, cGMPs, regulatory requirements, and safety protocols - Utilize tools such as Word, Excel, and electronic document management systems to complete tasks efficiently - Perform additional tasks as assigned by management Required Qualifications: - Bachelors' degree in Engineering, Science, or a related field of study - 0-2 years' experience in a GMP manufacturing environment - Familiar with regulatory (FDA) requirements - Advanced critical thinking and technical writing skills - Strong organizational, communication, and interpersonal skills Preferred Qualifications: - Experience in technical writing including drafting standard operating procedures, protocols, and/or reports is preferred - Business minor or coursework is strongly encouraged Required Skills: cGMP, FDA regulations, Validation, Qualification, SOP drafting, Protocol preparation, Report documentation, Equipment operation, Data collection, Microsoft Word, Microsoft Excel, Electronic document management systems Benefits: Medical, Dental, Vision, PTO, 401K