Maintenance Mechanic

Job Description Our client, a nationwide manufacturer of commercial pharmaceuticals, has an immediate need for an experienced Maintenance Mechanic , to join their winning team in Hunt Valley. Our candidate of choice will be responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. You will be responsible for the filtration and filling of a range of pharmaceutical products for clinical and commercial use. KEY RESPONSIBILITIES: Complete and maintain aseptic qualification training. Support and demonstrate skill set to Manufacturing Technician I and Manufacturing Technician II. Attain and maintain gowning qualification per appropriate SOPs. Follow SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail. Prepare and maintain accurate documentation following cGMP and GDP principles. Ensure documentations are completed in real-time in accordance to CGMP and GDP principles. Adhere to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions. Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed. Work collaboratively with internal teams to meet site goals and objectives as part of a team. Initiate and foster a spirit of cooperation within and between departments. Review documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA). Maintain all personal cGMP related training in a current state. Achieve and maintain cleaning and sanitization of cleanroom training. Participate in Aseptic media qualification per the appropriate qualification protocol. Support manufacturing in the investigation of deviations and performs required risk assessments. Participate in personnel monitoring as required. Work closely with Operational Excellence to identify and implement process improvements. Set up and breakdown the filling equipment per appropriate SOPs. Transport equipment and components as needed. Interact with filling machines at the validated speeds and volumes. Perform volume checks. Perform and document inherent and non-inherent interventions. Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment. Work with R&D and tech transfer team for successful transfer of Programs into the GMP area Perform all aseptic connections, respecting first air. Perform pre- and post-filter integrity testing as required. Aseptically sterile filter products into appropriate vessels. Complete routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed. Attain and maintain ability to perform environmental tasks as required. Additional duties, as assigned. KEY REQUIREMENTS: High school diploma or equivalent with 5+ years’ experience or Bachelor’s degree with a minimum of 3 years of experience. Prior experience in related field, preferred. Demonstrate the ability to work well in a cross-functional team environment. Basic math skills cGMP manufacturing knowledge, preferred. Aseptic filling and general production knowledge, preferred. Knowledge / Experience with electronic Quality Management Systems such as MasterControl Must be able to comprehend and follow all applicable SOPs Demonstrated ability to execute a task, unit operation and/or document (forms and/or SOPs) with little to no assistance. Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products. Demonstrate familiarity with Microsoft programs like Word, Excel, Teams and Outlook. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and managing priorities. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Must communicate fluently in English and have legible handwriting. #J-18808-Ljbffr