We have recently partnered with one of our customer's to provide direct hire recruiting services. By applying to this position you assume you are not applying to a direct full-time role within CAI. During the screening process, details surrounding the client's location and benefits will be provided.
Your responsibilities as Operations Performance Specialist will include:
Delivering solutions such as process maps and workflows, procedures, training programs and content, and staffing plans to support the operational readiness of new or expanding biotech and pharmaceutical manufacturing sites.
Support operational improvement / excellence in existing manufacturing sites through GMP floor observation and/or coaching, process and performance improvement development and execution, and performance-based deviation investigation and risk control.
Active in creating industry-changing approaches that help guide clients and the broader industry toward higher performance.
Participating in professional societies to support industry improvement and expand CAI’s store of knowledge.
BS in a science or engineering field or equivalent years’ experience
2+ years of experience in GMP Operations as Manufacturing Operator, Group Lead, Supervisor, and/or Manager
Experience in drug substance and/or drug product manufacturing including such systems/processes as Aseptic Filling lines, Lyophilizes, Depyrogenation, Vial Washer, Isolators, Bioreactors, AKTA skids, Fill skids, BSCs
Demonstrated experience in developing and/or continuous improvement in GMP on-floor operations, SOPs, Batch Records, and related processes / documentation
Demonstrated understanding of Good Documentation Practices
Lean practice education and experience is a plus
Superior oral and written communication skills in English, including communication with site supervision and management
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future