Overview. A fast-growing pharmaceutical manufacturing organization focused on supporting the development and manufacturing of sterile injectable drug products is seeking an experienced. Senior Process Engineer. to join the team, who is ready to utilize their knowledge within the sterile drug product filling operations, thrives in dynamic environments, excels at technical challenges, and is passionate about building robust, efficient, and scalable...
Key Responsibilities. Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements. Oversee document control, change management, deviation handling, CAPA, and training programs. Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections. Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold...
Responsibilities. Ensure full compliance with federal, state, and international regulations governing pharmaceutical and cold chain logistics, including biologics and vaccines. Support the implementation, maintenance, and continuous improvement of Quality Management System (QMS) procedures related to regulatory compliance. Review, create, and maintain SOPs, policies, and quality agreements to ensure alignment with current regulatory requirements....
Perform daily accounting activities including journal entries, account reconciliations, and general ledger maintenance. Support month-end and year-end close processes in accordance with GAAP. Prepare and reconcile balance sheet and income statement accounts. Assist with accounts payable and accounts receivable activities, including invoice processing and payment review. Support bank, credit card, and intercompany reconciliations. Assist in the pr...
Job Responsibilities. Perform calibration, maintenance, and troubleshooting of process and laboratory instrumentation, ensuring all equipment operates within defined tolerances and regulatory standards. Execute calibration tasks on a wide range of manufacturing and utility systems, including autoclaves, lyophilizers, temperature controllers, pressure gauges, and transmitters. Work independently to schedule, plan, and complete monthly calibration ...
Job Responsibilities. Perform and oversee routine and non-routine microbiological testing, including bioburden, endotoxin, sterility, microbial identification, growth promotion, and environmental monitoring. Lead investigations for microbiological deviations, out-of-specifications (OOS), and out-of-trends (OOT), including root cause analysis and CAPA development. Review and approve microbiological test data, reports, and batch records for accurac...
Job Responsibilities. Serve as the subject matter expert for plant and clean utilities, including boilers, chillers, chilled water, compressed air, WFI systems, clean steam, and HVAC equipment. Lead system ownership activities, including performance monitoring, troubleshooting, maintenance planning, and lifecycle management. Support facility and utility design efforts by reviewing drawings, interpreting Piping and Instrumentation Diagrams (P&IDs)...
Primary Responsibilities. Conduct testing of finished products, perform environmental monitoring, and carry out sterility quality control evaluations, documenting and reporting results accurately. Identify and escalate any non-conformances or deviations, managing these quality issues in accordance with established procedures. Assist with investigations related to deviations, OOS/OOT/OOE events, CAPA follow-ups, and implementation, as well as part...
Job Responsibilities. Develop, implement, and maintain training programs for Quality Control personnel, ensuring all team members are proficient in GMP procedures, laboratory techniques, and company quality systems. Conduct classroom, on-the-job, and hands-on training for new hires, existing staff, and cross-functional employees on QC methodologies, equipment operation, and regulatory compliance. Assess training needs through gap analysis, audits...
Key Responsibilities. Perform all activities associated with the manufacturing process, including setup, operation, and maintenance of production equipment and isolators. Ensure compliance with safety, environmental, and quality regulations while maintaining focus on key performance goals. Complete required training programs covering Standard Operating Procedures (SOPs), aseptic techniques, gowning, and health and safety practices. Support produc...
Responsibilities. Investigate and author reports on a range of deviating conditions or nonconforming events across multiple technical departments in collaboration with subject matter experts. Gather, analyze, and interpret information to provide evidence supporting investigation conclusions and root-cause determinations. Utilize analytical tools and methodologies to identify root causes and contributing factors. Develop robust corrective and prev...
