North Carolina Staffing
Technical Production Specialist I/II (NFB)
North Carolina Staffing, Clayton, North Carolina, United States, 27520
Grifols Technical Production Specialist
Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Technical Production Specialist
The Technical Production Specialist is responsible for designing, developing, implementing, conducting, monitoring and/or evaluating technical, cGMP for new and existing manufacturing equipment and processes. Support projects related to technical, cGMP, safety or administrative needs with guidance. Provides after-hours support for simple technical troubleshooting issues. Primary responsibilities for the role include: Schedule activities (i.e. fill, bulk, column run) to meet production schedule. Schedule materials (i.e. chemical filters) to support production run. Develop weekly production schedule per budget forecast. May consult other BUs (i.e. Engineering, Validation) regarding manufacturing concerns, conduct incident investigations and determine and implement corrective and preventive action. Identifies patterns or trends within the organization and participates in training needs assessments to develop recommendations for training interventions. May participate on startup and validation support projects. Contribute to investigation of simple incidents. Provides support after-hours for simple technical troubleshooting issues. Technical Production Specialist II
Must be able to perform all responsibilities described in the Technical Production Specialist job description. Primary responsibilities for the role include: Direct a small group of employees work/activities. Independently investigate simple incidents or contribute to investigation of greater complexity. Participate/schedule non-routine activities to avoid impact to the production schedule (i.e. media, validation runs, non-routine sampling support, column packaging/reslurry, UF cassette change out, etc.) Participate in non-routine activities to evaluate CAPAS for type (1) incidents. Identifies patterns or trends within the process and participates in evaluating potential process/equipment changes in response. Sr. Technical Production Specialist
Must be able to perform all responsibilities described in the Technical Production Specialist II job description. Primary responsibilities for the role include: May supervise a small group of employees. Independently investigate complex incidents. Advance technical project proposal to Senior Management, following through to successful completion. Responsible for allocation of resources at division/department level for projects and incident resolution. Provide input for budget forecasting for production scheduling operations. Serve as an SME for manufacturing processes, equipment, workflow, documents and projects for the BU, peer BU and partner groups. Education & Experience: Technical Production Specialist: BS/BA degree in a relevant field and 4 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be knowledgeable in 2-4 Unit Operations and 1-2 functions or 1-2 departments. Technical Production Specialist II: BS/BA degree in a relevant field and 6 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be a SME in 4 Unit Operations and 2 functions or 2 departments. Sr. Technical Production Specialist: BS/BA degree in a relevant field and 7 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be a SME in 6+ Unit Operations and 3 functions or 3 departments. Unit Operations are defined as: Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, and Viral Inactivation. Functions are defined as: Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling. Departments are defined as: Manufacturing departments. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Technical Production Specialist
The Technical Production Specialist is responsible for designing, developing, implementing, conducting, monitoring and/or evaluating technical, cGMP for new and existing manufacturing equipment and processes. Support projects related to technical, cGMP, safety or administrative needs with guidance. Provides after-hours support for simple technical troubleshooting issues. Primary responsibilities for the role include: Schedule activities (i.e. fill, bulk, column run) to meet production schedule. Schedule materials (i.e. chemical filters) to support production run. Develop weekly production schedule per budget forecast. May consult other BUs (i.e. Engineering, Validation) regarding manufacturing concerns, conduct incident investigations and determine and implement corrective and preventive action. Identifies patterns or trends within the organization and participates in training needs assessments to develop recommendations for training interventions. May participate on startup and validation support projects. Contribute to investigation of simple incidents. Provides support after-hours for simple technical troubleshooting issues. Technical Production Specialist II
Must be able to perform all responsibilities described in the Technical Production Specialist job description. Primary responsibilities for the role include: Direct a small group of employees work/activities. Independently investigate simple incidents or contribute to investigation of greater complexity. Participate/schedule non-routine activities to avoid impact to the production schedule (i.e. media, validation runs, non-routine sampling support, column packaging/reslurry, UF cassette change out, etc.) Participate in non-routine activities to evaluate CAPAS for type (1) incidents. Identifies patterns or trends within the process and participates in evaluating potential process/equipment changes in response. Sr. Technical Production Specialist
Must be able to perform all responsibilities described in the Technical Production Specialist II job description. Primary responsibilities for the role include: May supervise a small group of employees. Independently investigate complex incidents. Advance technical project proposal to Senior Management, following through to successful completion. Responsible for allocation of resources at division/department level for projects and incident resolution. Provide input for budget forecasting for production scheduling operations. Serve as an SME for manufacturing processes, equipment, workflow, documents and projects for the BU, peer BU and partner groups. Education & Experience: Technical Production Specialist: BS/BA degree in a relevant field and 4 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be knowledgeable in 2-4 Unit Operations and 1-2 functions or 1-2 departments. Technical Production Specialist II: BS/BA degree in a relevant field and 6 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be a SME in 4 Unit Operations and 2 functions or 2 departments. Sr. Technical Production Specialist: BS/BA degree in a relevant field and 7 years of related experience or an equivalent combination of education and experience may be considered. In addition, he/she must be a SME in 6+ Unit Operations and 3 functions or 3 departments. Unit Operations are defined as: Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, and Viral Inactivation. Functions are defined as: Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling. Departments are defined as: Manufacturing departments. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.