Description:
Independently lead the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply advanced process, operational, scientific expertise, compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Serve as the primary production process owner for critical process systems or an operational area. May supervise Manufacturing.
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Lead trouble shooting of production process equipment. Generate training materials and provide training on scientific or technical aspects of the process. Participate in the design of critical processes and/or facilities.
Considered to be subject matter expert in an operational area. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. In conjunction with PD own process-monitoring parameters and control limits. Review process-monitoring data and assess deviations. Approve routine reports. Initiate corrective actions due to process-monitoring deviations. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Responsible to lead more complex investigations. Lead NC/CAPA trend evaluation. May be responsible for all management level NCs and associated CAs for a functional area. Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May generate and approve process validation protocols and reports. Lead execution of process validation. Lead major process validation projects. May participate in regulatory inspections. Review and provide input to regulatory submissions applicable to area of responsibility. Support gathering of data and formulation of responses during and after regulatory inspections. Respond to inspector questions as necessary. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc.
May present process overviews to inspectors and accompany inspectors on tours of process areas. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Develop NPI timelines including milestones and deliverables. Communicate with NPI stakeholders on timelines progress. Serve as NPI core team leader. Able to lead multi-departmental teams and facilitate decision-making. Ensure appropriate resources are in place to perform NPI activities. Write NPI campaign summaries
Represent manufacturing on the Global Operational Teams(GOTs). Assist manufacturing change owner on CCRB packages impacting the process. Serve as the manufacturing change owner on CCRB packages impacting the process. Participate on the assessment or implementation of special projects or initiatives. Assist area manager in prioritization of projects. Serve as production project manager in manufacturing projects and cross functional projects.* Other functions may be assigned.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS
Advanced organizational, technical writing and presentation skills. Excellent project management skills.
